meddevicedb.com FDA Device Reference

Review Panel

Pathology FDA 510(k) Clearances & Devices

Cleared Devices
343
Product Codes (page)
33
Latest Decision
1988-04-18

Clearances · page 2 of 4

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K881467 MICROSCOPE STAGE HEATER Cryodyne Technologies, Inc. KEJ Class I 1988-04-18
K881282 XYLENE Anatech, Ltd. KEM Class I 1988-04-05
K880549 DIACYTE FIXATIVE SOLUTION Cytocorp, Inc. LDY Class I 1988-04-01
K874887 WESBLOT PROCESSOR American Bionetics, Inc. KPA Class I 1988-03-24
K875122 DISPOSABLE STERILE SYRINGE FILTERS Corning Medical & Scientific KET Class I 1988-01-12
K874190 CELL COUNTING GRID GRATICULE Portable Medical Laboratories, Inc. IBJ Class I 1988-01-05
K874897 SAKURA DRS-60 AUTOMATIC SLIDE STAINER Sakura Finetek U.S.A., Inc. KPA Class I 1988-01-05
K874207 THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION Intl. Remote Imaging Systems IBJ Class I 1988-01-05
K874461 HEMO-SOL Chem Pharm, Inc. KEM Class I 1987-12-04
K873593 BIOSURE SPECIMEN COLLECTION CONTAINER Biosure, Inc. KDT Class I 1987-11-25
K873594 TIF FECAL TEST Devetec, Inc. LEA Class I 1987-09-29
K872916 HISTOMATIC SLIDE STAINER, CODE-ON VERSION Fisher Scientific Co., LLC KPA Class I 1987-09-14
K872874 MICROSCOPE COVER GLASSES Abco Dealers, Inc. KES Class I 1987-08-10
K872625 DECALCIFYING SOLUTION Stephens Scientific KDX Class I 1987-08-06
K872663 DRY-FORM Anatech, Ltd. IFP Class I 1987-08-06
K872140 (MSI) PATH-SAVER Medical Specialties, Inc. IFP Class I 1987-06-15
K870196 PCTE MICROPOROUS MEMBRANE FILTER Poretics Corp. KET Class I 1987-05-12
K871533 TOMTEC GRAM STAINER DECOLORIZER Remel Co. PPM Class I 1987-04-29
K870852 NBF 10% NEUTRAL BUFFERED FORMALIN Anatech, Ltd. IFP Class I 1987-03-31
K864733 LKB 2260 MACROTOME Lkb Instruments, Inc. IDO Class I 1987-01-05
K864049 MCARTHUR MICROSCOPE, STANDARD METAL VERSION Portable Medical Laboratories, Inc. IBJ Class I 1986-10-29
K863550 POTASSIUM HYDROXIDE 10% W/V Reagent Laboratory, Inc. PPM Class I 1986-10-02
K863616 KNIFE MAKER Surgipath Medical Industries, Inc. IDL Class I 1986-09-25
K863548 ROTARY MICROTOME Surgipath Medical Industries, Inc. IDO Class I 1986-09-19
K863483 CASSETTE EMBOSSEER Surgipath Medical Industries, Inc. IDZ Class I 1986-09-16
K862665 NOVACYTE-U Xsirius Medical, Inc. KDT Class I 1986-09-04
K862725 SACCOMANNO SPECIMAN SOLUTION Mill-Rose Laboratory LDZ Class I 1986-08-01
K862457 LYNX EL MICROSCOPY TISSUE PROCESSOR Australian Biomedical Corporation , Ltd. IDZ Class I 1986-07-16
K862223 MICRO THIN* PARAFFIN Richard-Allan Medical Ind., Inc. KEO Class I 1986-06-17
K862141 HISTOLOGY PARAFFIN Erie Scientific Co. KEO Class I 1986-06-13
K861890 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 Richard-Allan Medical Ind., Inc. PPM Class I 1986-06-03
K861490 PERMACLEAR SOLUTION CAT. NO. 4950 Helena Laboratories KEM Class I 1986-05-06
K861270 BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. Surgipath Medical Industries, Inc. KEO Class I 1986-04-11
K861201 FORMALDEHYDE SOLUTION, 37% Surgipath Medical Industries, Inc. IGG Class I 1986-04-11
K855034 AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT Bartels Immunodiagnostic Supplies, Inc. LIJ Class I 1986-03-11
K855109 CLEARENE, CLEARING AGENT Surgipath Medical Industries, Inc. KEM Class I 1986-01-07
K854735 MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. Portable Medical Laboratories, Inc. IBJ Class I 1985-12-10
K853861 CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 Canon USA, Inc. IJZ Class I 1985-10-24
K854083 XYLENE SUBSTITUTE MONTANT Lerner Laboratories, Inc. KEM Class I 1985-10-22
K853694 XYLENE SUBSTITUTE Lerner Laboratories, Inc. KEM Class I 1985-10-22
K853210 MST-1050-II X-RAY UNIT Radiological Engineering, Inc. KPA Class I 1985-10-10
K853938 LX 300 TISSUE PROCESSOR Innovative Medical Systems, Inc. IEO Class I 1985-10-10
K853497 PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN Surgipath Medical Industries, Inc. IFP Class I 1985-08-28
K852045 SED-FIX CONCENTRATE Surgipath Medical Industries, Inc. IER Class I 1985-06-10
K852117 CYTO-TEK CENTRIFUGE Miles Laboratories, Inc. IFB Class I 1985-06-10
K851054 LX120 TISSUE PROCESSOR Innovative Medical Systems, Inc. IEO Class I 1985-05-15
K850916 SPRAYFIX Surgipath Medical Industries, Inc. PPM Class I 1985-03-25
K850845 0.85% SALINE Micro Media Laboratories PPM Class I 1985-03-20
K850737 TRANSPORT CULTURE MEDIUM Roseville Medical Laboratoriesu PPM Class I 1985-03-20
K850636 SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E Fisher Scientific Co., LLC KDX Class I 1985-03-20
K850157 CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS Shaban Mfg. Co. KPA Class I 1985-02-27
K850333 PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS Shaban Mfg. Co. KPA Class I 1985-02-27
K844671 CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON Corning Medical & Scientific KET Class I 1985-02-25
K843505 LKB 2230 ROTARY ONE Lkb Instruments, Inc. IDO Class I 1984-11-30
K843506 LKB 2189 ULTROPROCESSOR Lkb Instruments, Inc. IEO Class I 1984-11-30
K842982 FORMALIN BUFFERED Reagent Laboratory, Inc. IFP Class I 1984-10-01
K843428 BIOFIX Accra Laboratories, Inc. LDZ Class I 1984-09-27
K842934 DECOLORIZING FLUIC, ACID-ALCOHOL 3% E K Ind., Inc. PPM Class I 1984-09-12
K842918 SCOTTS TAP WATER SUBSTITUTE E K Ind., Inc. JCC Class I 1984-09-11
K842731 FORMALIN-ACETO-ALCOHOL FIXATIVE E K Ind., Inc. IGF Class I 1984-09-11
K842923 PICRIC ACID 1% W/V E K Ind., Inc. LDW Class I 1984-09-11
K842722 BUFFERED SALINE E K Ind., Inc. JCE Class I 1984-09-11
K842737 CARNOY'S SOLUTION E K Ind., Inc. IGM Class I 1984-09-07
K842913 WRIGHT STAIN FIXATIVE E K Ind., Inc. LDZ Class I 1984-09-07
K842922 PICRIC ACID SATURATED SOLUTION E K Ind., Inc. LDW Class I 1984-09-07
K842914 WRIGHT STAIN BUFFER E K Ind., Inc. JCC Class I 1984-09-07
K842940 CBA FORMALIN Anatech, Ltd. IFP Class I 1984-08-28
K842862 CB FORMALIN Anatech, Ltd. IGE Class I 1984-08-28
K842986 REFRAX MOUNTING MEDIUM Anatech, Ltd. LEB Class I 1984-08-21
K842861 PRO-PAR CLEARANT Anatech, Ltd. KEM Class I 1984-08-21
K842863 PRO-SOFT DEHYDRANT Anatech, Ltd. PPM Class I 1984-08-21
K842726 DECALCIFIER SOLUTION E K Ind., Inc. KDX Class I 1984-08-03
K842721 LIMONENE E K Ind., Inc. KEM Class I 1984-08-03
K842728 BUF-FIX E K Ind., Inc. IFP Class I 1984-08-03
K842732 ZENKERS SOLUTION E K Ind., Inc. IFH Class I 1984-08-03
K842729 DECOLORIZING FLUID E K Ind., Inc. PPM Class I 1984-08-03
K842077 MIDAS II AUTOMATIC STAINER Innovative Medical Systems, Inc. KPA Class I 1984-07-27
K842070 IDD DETERGENT Interscience Diagnostics, Inc. PPM Class I 1984-07-02
K842053 PARAPLAST EXTRA TISSUE EMBEDDING MED. Sherwood Medical Co. KEO Class I 1984-06-26
K841423 SCOTTS TAP WATER SUBSTITUTE 7 Reagent Laboratory, Inc. JCC Class I 1984-05-22
K841488 DECALCIFIER I Surgipath Medical Industries, Inc. KDX Class I 1984-05-02
K840926 FORMALIN SOLUTION 10% NEUTRAL BUFFER Sigma Chemical Co. IFP Class I 1984-03-12
K840556 DISPOSABLE SYRINGE FILTERS Corning Medical & Scientific KET Class I 1984-03-05
K834579 BIOSPAL 2400S Hospal Medical Corp. KDT Class I 1984-02-04
K834599 AUTOTECHNICON V TISSUE PROCESS SYS Technicon Instruments Corp. IEO Class I 1984-02-04
K834412 PRESERV PVA FIXATIVE 15ML-FORMALIN PK Preventive Diagnostics Corp. KDT Class I 1984-01-13
K833857 MACLEAN-FOGG, TISSUE CASSETTES Polymer Technology Corp. IDZ Class I 1983-12-02
K833660 PRESERV PVA FIXATIVE -MALIN PACK Preventive Diagnostics Corp. KDT Class I 1983-11-28
K833515 BOUINS SOLUTION Sigma Chemical Co. IGN Class I 1983-11-14
K833295 WESCOR 7100 AEROSPRAY SLIDE STAINER Wescor, Inc. KPA Class I 1983-10-31
K833071 TECHNICON PARACUT Technicon Instruments Corp. KEO Class I 1983-10-14
K832994 MIDAS 6000 AUTOMATIC STAINER Innovative Medical Systems, Inc. KPA Class I 1983-09-29
K832451 CLEAR-RITE 3 Richard-Allan Medical Ind., Inc. KEM Class I 1983-08-12
K832011 AMERI CLEAR Stephens Scientific KEM Class I 1983-08-12
K831922 EMBEDDING RING Polymer Technology Corp. KER Class I 1983-07-29
K831921 DISPOSABLE MICROTOME BLADES Polymer Technology Corp. IDL Class I 1983-07-29
K831619 SODIUM HYPOCHLORITE 7% Omega Medical Diagnostics PPM Class I 1983-07-28
K831900 MACLEAN-FOGG, DISP. BASE MOLD Polymer Technology Corp. KER Class I 1983-07-28
K831313 TISSUE-TEK V.I.P. 100/200 Miles Laboratories, Inc. IEO Class I 1983-07-28
K831620 SODIUM HYPOCHLORITE 3% Omega Medical Diagnostics PPM Class I 1983-07-28

343 clearances in the Pathology panel. Data: openFDA.