FDA Product Code
FDA Product Code FRC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2800
510(k) Clearances — 206 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111375 | STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR | Advanced Sterilization Products | 2012-09-14 | Traditional | PDF ↗ |
| K113221 | NAMSA BIOLOGICAL INDICATOR SPORE STRIPS | North American Science Assoc., Inc. | 2012-04-27 | Traditional | PDF ↗ |
| K111515 | SPSMEDICAL SPORVIEW STEAM BI | Spsmedical Supply Corp. | 2012-02-01 | Traditional | PDF ↗ |
| K112018 | SMART READ EZTEST STEAM | Mesa Laboratories, Inc. | 2012-01-30 | Traditional | PDF ↗ |
| K113302 | NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS | North American Science Assoc., Inc. | 2012-01-20 | Abbreviated | PDF ↗ |
| K111150 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | Steritec Products Mfg Co, Inc. | 2011-07-08 | Traditional | PDF ↗ |
| K103277 | 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER | 3M Company-3M Health Care | 2011-04-19 | Traditional | PDF ↗ |
| K103222 | STERRAD CYCLESURE BIOLOGICAL INDICATOR | Advanced Sterilization Products | 2011-02-25 | Traditional | PDF ↗ |
| K092755 | STERRAAD 100NX EXPRESS CYCLE TEST PACK | Advanced Sterilization Products | 2011-02-25 | Traditional | PDF ↗ |
| K103321 | DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES | Dana Products, Inc. | 2011-02-16 | Traditional | PDF ↗ |
| K102884 | STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR | Advanced Sterilization Products | 2011-01-28 | Traditional | PDF ↗ |
| K101910 | 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS | 3M Company | 2010-12-08 | Traditional | PDF ↗ |
| K093794 | SMART-READ EZTEST-STEAM SCBI AND TEST PACK | Sgm Biotech, Inc. | 2010-05-14 | Special | PDF ↗ |
| K092944 | DANA REUSABLE TEST PACK FOR STEAM STERILIZATION | Dana Products, Inc. | 2010-03-18 | Traditional | PDF ↗ |
| K091950 | SMART-WELL EZTEST INCUBATOR | Sgm Biotech, Inc. | 2010-01-15 | Traditional | PDF ↗ |
| K092906 | VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION | STERIS Corporation | 2009-12-30 | Traditional | PDF ↗ |
| K082756 | RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR | Raven Biological Laboratories, Inc. | 2009-10-21 | Traditional | PDF ↗ |
| K083665 | VERIFY SCBI 275F 3-10 | STERIS Corporation | 2009-09-01 | Abbreviated | PDF ↗ |
| K090569 | MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 | 3M Company | 2009-04-29 | Special | PDF ↗ |
| K090514 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES | STERIS Corporation | 2009-03-16 | Special | PDF ↗ |
| K073618 | VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK | STERIS Corporation | 2009-01-07 | Traditional | PDF ↗ |
| K073244 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES | STERIS Corporation | 2008-05-28 | Traditional | PDF ↗ |
| K071537 | STERRAD 100NX TEST PACK | Advanced Sterilization Products | 2007-12-18 | Traditional | PDF ↗ |
| K070595 | SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR | Spsmedical Supply Corp. | 2007-05-24 | Traditional | PDF ↗ |
| K071014 | MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR | Advanced Sterilization Products | 2007-05-24 | Special | PDF ↗ |
| K051056 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR | Albert Browne , Ltd. | 2005-10-20 | Traditional | PDF ↗ |
| K051643 | STERRAD STERILIZER CYCLESURE TEST PACK | Advanced Sterilization Products | 2005-08-19 | Traditional | PDF ↗ |
| K052128 | 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER | 3M Company | 2005-08-16 | Special | PDF ↗ |
| K051173 | SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK | Spsmedical Supply Corp. | 2005-05-27 | Special | PDF ↗ |
| K042450 | STERRAD NX CHALLENGE PACK | Advanced Sterilization Products | 2005-05-12 | Traditional | PDF ↗ |
| K050664 | SPOR-TEST PA BIOLOGICAL INDICATOR KIT | Getinge USA, Inc. | 2005-04-07 | Special | PDF ↗ |
| K050591 | MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS | Raven Biological Laboratories, Inc. | 2005-03-23 | Special | PDF ↗ |
| K041784 | RAVEN PROTEST - EO | Raven Biological Laboratories, Inc. | 2004-09-13 | Traditional | PDF ↗ |
| K041386 | RAVEN PROTEST - STEAM | Raven Biological Laboratories, Inc. | 2004-08-09 | Traditional | PDF ↗ |
| K032914 | MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS | Raven Biological Laboratories, Inc. | 2004-05-25 | Traditional | PDF ↗ |
| K041099 | MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP | Spsmedical Supply Corp. | 2004-05-06 | Special | PDF ↗ |
| K031012 | ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK | 3M Company | 2003-10-16 | Traditional | PDF ↗ |
| K032723 | BIOSIGN STEAM-24 BIOLOGICAL INDICATOR | Getinge USA, Inc. | 2003-10-01 | Special | PDF ↗ |
| K031226 | STERRAD CYCLESURE BIOLOGICAL INDICATOR | Advanced Sterilization Products | 2003-05-02 | Special | PDF ↗ |
| K024079 | ALIBI BIOLOGICAL INDICATOR, MODEL WS | Arden Laboratories, Incorporated | 2003-02-27 | Abbreviated | PDF ↗ |
| K023716 | SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP | Spsmedical Supply Corp. | 2002-12-05 | Special | PDF ↗ |
| K022706 | SPSMEDICAL SPORVIEW STEAM BI TEST PACK | Spsmedical Supply Corp. | 2002-10-25 | Traditional | PDF ↗ |
| K020205 | CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT | Getinge/Castle, Inc. | 2002-06-24 | Traditional | PDF ↗ |
| K004009 | 3M ATTEST 290 AUTO-READER | 3M Company | 2002-03-25 | Traditional | PDF ↗ |
| K994055 | STERRAD CYCLESURE BIOLOGICAL INDICATOR | Advanced Sterilization Products | 2002-02-13 | Traditional | PDF ↗ |
| K020026 | RAVEN BACTERIAL SPORE STRIPS | Raven Biological Laboratories, Inc. | 2002-01-30 | Special | PDF ↗ |
| K994381 | PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR | Raven Biological Laboratories, Inc. | 2001-03-30 | Traditional | PDF ↗ |
| K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR | Propper Mfg. Co., Inc. | 2001-01-24 | Traditional | PDF ↗ |
| K993775 | STERRAD BI TEST PACK | Advanced Sterilization Products | 2000-06-01 | Traditional | PDF ↗ |
| K991675 | MODIFICATION OF: STERRAD BI TEST PACK | Advanced Sterilization Products | 1999-06-15 | Special | PDF ↗ |
| K981497 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS | Steritec Products Mfg Co, Inc. | 1998-10-29 | Traditional | PDF ↗ |
| K972747 | BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) | Propper Mfg. Co., Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K971430 | PROSPORE II | Raven Biological Laboratories, Inc. | 1997-05-22 | Traditional | PDF ↗ |
| K971432 | PROSPORE | Raven Biological Laboratories, Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K930683 | EZTEST-GAS | Sgm Biomedical, Inc. | 1997-03-04 | Traditional | PDF ↗ |
| K963841 | EZTEST | Sgm Biotech, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K962441 | PROSPORE(STEARO FOR STEAM STERILIZER) | Raven Biological Laboratories, Inc. | 1996-09-18 | Traditional | PDF ↗ |
| K961721 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK | Steritec Products Mfg Co, Inc. | 1996-08-23 | Traditional | PDF ↗ |
| K960790 | PROSPORE II | Raven Biological Laboratories, Inc. | 1996-08-16 | Traditional | PDF ↗ |
| K960777 | MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR | Mdt Corp., Inc. | 1996-05-23 | Traditional | PDF ↗ |
| K926364 | ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X | 3M Health Care, Ltd. | 1995-03-31 | Traditional | PDF ↗ |
| K923739 | ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR | Abtox, Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K930682 | EZTEST-STEAM | Sgm Biotech, Inc. | 1994-04-04 | Traditional | PDF ↗ |
| K925496 | ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK | Pymah Corp. | 1994-02-01 | Traditional | PDF ↗ |
| K925745 | ATI(R) DISP BIOLOGICAL-PLUS TEST PACK | Pymah Corp. | 1994-02-01 | Traditional | PDF ↗ |
| K921909 | STERRAD BI TEST PACK | Johnson & Johnson Medical, Inc. | 1993-10-01 | Traditional | PDF ↗ |
| K922212 | MDT CASTLE BIOSIGN TEST PACK | Mdt Corp., Inc. | 1992-08-10 | Traditional | PDF ↗ |
| K912796 | SPORE STRIP | Raven Biological Laboratories, Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K905425 | SPORVIEW | Spsmedical Supply Corp. | 1992-03-27 | Traditional | PDF ↗ |
| K910417 | EVIDENCE BIOLOGICAL INDICATOR | Skyland Scientific Services, Inc. | 1991-03-08 | Traditional | PDF ↗ |
| K903024 | BI-O.K. STEAM TEST-PAK | Propper Mfg. Co., Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K902344 | ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER | Ati | 1990-07-19 | Traditional | PDF ↗ |
| K900771 | ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR | 3M Company | 1990-07-03 | Traditional | PDF ↗ |
| K895704 | ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE | Pymah Corp., Ati Div. | 1990-03-08 | Traditional | PDF ↗ |
| K891784 | BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR | Propper Mfg. Co., Inc. | 1990-02-09 | Traditional | PDF ↗ |
| K890754 | SPORVIEW CULTURE MEDIA | Spsmedical Supply Corp. | 1989-11-17 | Traditional | PDF ↗ |
| K894398 | STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE | Pymah Corp. | 1989-09-11 | Traditional | PDF ↗ |
| K894399 | STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI. | Pymah Corp. | 1989-09-11 | Traditional | PDF ↗ |
| K891366 | BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.) | Mdt Corp., Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K884615 | ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK | Pymah Corp., Ati Div. | 1989-01-19 | Traditional | PDF ↗ |
| K884767 | ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK | Pymah Corp., Ati Div. | 1989-01-10 | Traditional | PDF ↗ |
| K872867 | BIOSIGN | Clinical Technology Corp. | 1988-07-06 | Traditional | PDF ↗ |
| K863122 | ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. | Surgicot, Inc. | 1986-12-17 | Traditional | PDF ↗ |
| K855101 | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR | Surgicot, Inc. | 1986-07-17 | Traditional | PDF ↗ |
| K855120 | ATI DISPOSABLE BIOLOGICAL TEST PACK | Parke-Davis Co. | 1986-06-18 | Traditional | PDF ↗ |
| K854631 | ASSERT EO BIOLOGICAL TEST PACK | Surgicot, Inc. | 1986-05-27 | Traditional | PDF ↗ |
| K854902 | SURGICOT STEAM TEST PACK | Surgicot, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K844479 | CHEMSPOR | American Sterilizer Co. | 1985-11-25 | Traditional | PDF ↗ |
| K852192 | DISPOSABLE STEAM BIOLOGICAL TEST PACK | Parke-Davis Co. | 1985-11-01 | Traditional | PDF ↗ |
| K850144 | BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH | American Sterilizer Co. | 1985-06-17 | Traditional | PDF ↗ |
| K841709 | 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP | Skyland Scientific Services, Inc. | 1984-10-02 | Traditional | PDF ↗ |
| K841583 | SPORSTRIP | Skyland Scientific Services, Inc. | 1984-05-25 | Traditional | PDF ↗ |
| K832922 | TRAVASPORE BIOLOGICAL INDICATOR | Travenol Laboratories, S.A. | 1983-11-21 | Traditional | PDF ↗ |
| K822024 | BACILLU S SUBTILIS BIOLOGICAL INDICA. | Findley Research, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K812272 | CASTLE TEC-TEST BIOLOGICAL INDICATOR | Sybron Corp. | 1981-09-08 | Traditional | PDF ↗ |
| K810930 | BACILLUM PUMILUS SPORE STRIPS | Oxoid U.S.A., Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K802228 | BIOLOGICAL INDICATOR - KEMMED & BIOSURE | Kem Medical Products Corp. | 1980-12-09 | Traditional | PDF ↗ |
| K801678 | SPOR-TEST-STRIP | Sterilization Technical Services, Inc. | 1980-08-13 | Traditional | PDF ↗ |
| K800482 | STEAROTHERMOHILUS SPORE STRIPS | Mdt Corp., Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800029 | SURGICOT 2 INDICATOR SYSTEM | Surgicot, Inc. | 1980-03-12 | Traditional | PDF ↗ |
Product code FRC · Class II · General Hospital. Data: openFDA.