FDA Product Code
FDA Product Code JPK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8625
510(k) Clearances — 192 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K871067 | MSI HEMATOLOGY CONTROL + | Medical Specialties, Inc. | 1987-03-25 | Traditional | PDF ↗ |
| K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | Fisher Scientific Co., LLC | 1986-10-29 | Traditional | PDF ↗ |
| K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR | Fisher Scientific Co., LLC | 1986-07-10 | Traditional | PDF ↗ |
| K862186 | LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II | Bio-Rad | 1986-07-01 | Traditional | PDF ↗ |
| K860751 | VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA | Bio/Data Corp. | 1986-03-18 | Traditional | PDF ↗ |
| K854353 | PLATELET-TROL II | R&D Systems, Inc. | 1985-11-26 | Traditional | PDF ↗ |
| K852992 | PARA CHECK (AKA EIGHT CHECK-C) | Streck Laboratories, Inc. | 1985-10-10 | Traditional | PDF ↗ |
| K853776 | MSI-HB HEMOGLOBIN CONTROL | Medical Specialties, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K852372 | CELL-DYN BRAND HEMATOLOGY REAGENTS | Abbott Diagnostics | 1985-09-03 | Traditional | PDF ↗ |
| K851663 | QUICK-COUNT HEMATOLOGY CONTROLS | Seragen Diagnostics, Inc. | 1985-07-23 | Traditional | PDF ↗ |
| K851375 | TRI-COUNT | Hematology Marketing Assoc. | 1985-07-12 | Traditional | PDF ↗ |
| K850755 | CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL | R&D Systems, Inc. | 1985-05-13 | Traditional | PDF ↗ |
| K850250 | TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH | Technicon Instruments Corp. | 1985-04-01 | Traditional | PDF ↗ |
| K844897 | HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 | Medical Specialties Laboratories | 1985-03-22 | Traditional | PDF ↗ |
| K844928 | QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE | Bhp Diagnostix, Inc. | 1985-03-22 | Traditional | PDF ↗ |
| K844927 | QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS | Bhp Diagnostix, Inc. | 1985-03-22 | Traditional | PDF ↗ |
| K843805 | COULTER CHECK SAMPLE UNASSAYED HEMATOLOG | Coulter Electronics, Inc. | 1984-12-17 | Traditional | PDF ↗ |
| K843485 | TRI-COUNT LASER | Hematology Marketing Assoc. | 1984-12-12 | Traditional | PDF ↗ |
| K841809 | COUNT-A-PART PLUS | Diagnostic Technology, Inc. | 1984-11-30 | Traditional | PDF ↗ |
| K843962 | CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE | R&D Systems, Inc. | 1984-11-01 | Traditional | PDF ↗ |
| K843093 | RETIC-CHEX | Streck Laboratories, Inc. | 1984-10-23 | Traditional | PDF ↗ |
| K842286 | DIA T1, T2 & T3 | Diatech, Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K842109 | TECHNICON TEST POINT ASSAYED HEMATOLOGY | Technicon Instruments Corp. | 1984-07-27 | Traditional | PDF ↗ |
| K841531 | PARA-TEK | Streck Laboratories, Inc. | 1984-07-27 | Traditional | PDF ↗ |
| K842440 | SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH | Anco Medical Reagents & Assoc. | 1984-07-27 | Traditional | PDF ↗ |
| K842017 | PARA 4 | Streck Laboratories, Inc. | 1984-06-26 | Traditional | PDF ↗ |
| K841239 | ASSIGNED VALUE FOR MEAN PLATELET | Coulter Electronics, Inc. | 1984-05-02 | Traditional | PDF ↗ |
| K840302 | PLT - 4 PLATELET | R&D Systems, Inc. | 1984-03-12 | Traditional | PDF ↗ |
| K834371 | TRI-COUNT 10 | Hematology Marketing Assoc. | 1984-03-09 | Traditional | PDF ↗ |
| K833563 | HC PLUS | Coulter Electronics, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K834043 | MSI-HC HEMATOLOGY CONTROL | Medical Specialties, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K833130 | TRI-COUNT 7 | Hematology Marketing Assoc. | 1983-10-20 | Traditional | PDF ↗ |
| K831704 | TECHNICON H6000 SYSTEM CONTROL | Technicon Instruments Corp. | 1983-07-06 | Traditional | PDF ↗ |
| K830864 | WHITE BLOOD CELL CONTROL | Control Diagnostics | 1983-06-15 | Traditional | PDF ↗ |
| K831094 | PARA LASAR | Streck Laboratories, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K820731 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | Fisher Scientific Co., LLC | 1982-05-12 | Traditional | PDF ↗ |
| K820401 | ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW | Orhto Diagnostic Systems, Inc. | 1982-03-15 | Traditional | PDF ↗ |
| K820400 | ORTHO* HEMATOLOGY CONTROL 8 NORMAL | Ortho Diagnostic Systems, Inc. | 1982-03-15 | Traditional | PDF ↗ |
| K812280 | HEMATOLOGY CONTROL | American Dade | 1981-09-09 | Traditional | PDF ↗ |
| K812237 | HEMOTOLOGY QUALITY CONTROL MIXTURE | American Dade | 1981-09-09 | Traditional | PDF ↗ |
| K812357 | VENTREX DATA REDUCTION & QUAL. CONTR. SY | Ventrex Laboratories, Inc. | 1981-09-01 | Traditional | PDF ↗ |
| K810756 | HEMOTOLOGY QUALITY CONTROL MIXTURES | Scientific Standards, Inc. | 1981-06-30 | Traditional | PDF ↗ |
| K801054 | THROMBO-TEST (X) | Medtro GmbH | 1981-03-13 | Traditional | PDF ↗ |
| K803083 | ORTHO HEMOTOLOGY CONTROL-NORMAL | Ortho Instruments | 1980-12-31 | Traditional | PDF ↗ |
| K803084 | ORTHO HEMATOLOGY CONTROL ABNORMAL LOW | Ortho Instruments | 1980-12-31 | Traditional | PDF ↗ |
| K803073 | ORTHO HEMATOLOGY CONTROL | Ortho Instruments | 1980-12-31 | Traditional | PDF ↗ |
| K802267 | PLT-4 SIZE-CHECK | R&D Systems, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802265 | CBC PLT-4 | R&D Systems, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802142 | CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL | American Dade | 1980-10-10 | Traditional | PDF ↗ |
| K802143 | CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET | American Dade | 1980-10-10 | Traditional | PDF ↗ |
| K802141 | CH-60 PLUS WHOLE BLOOD PLATELET CONTROL | American Dade | 1980-10-10 | Traditional | PDF ↗ |
| K801265 | WHITE BLOOD CELL COUNT CONTROL LEVELS | Bioscientific | 1980-07-14 | Traditional | PDF ↗ |
| K801267 | RED BLOOD CELL COUNT & HEMATOCRIT CNTL | Bioscientific | 1980-07-14 | Traditional | PDF ↗ |
| K800938 | TRI-CHECK | Scientific Standards, Inc. | 1980-05-08 | Traditional | PDF ↗ |
| K800780 | SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS | Sandare Chemical Co., Inc. | 1980-04-24 | Traditional | PDF ↗ |
| K800361 | HEMATO-CHEX | Streck Laboratories, Inc. | 1980-04-04 | Traditional | PDF ↗ |
| K792606 | WHOLE BLOOD PLATELET CONTROL NORMAL, | Dade, Baxter Travenol Diagnostics, Inc. | 1980-02-13 | Traditional | PDF ↗ |
| K792467 | PLATELET-CHEX FOR BLOOD CENTERS | Streck Laboratories, Inc. | 1979-12-31 | Traditional | PDF ↗ |
| K792209 | SANDARE HEMOGLOBIN CONTROLS | Sandare Chemical Co., Inc. | 1979-12-04 | Traditional | PDF ↗ |
| K792055 | FISHER DIAGNOSTICS HEMATOLOGY CONTROLS | Fisher Scientific Co., LLC | 1979-11-05 | Traditional | PDF ↗ |
| K791750 | COUNTER-CHECK PLUS | Diagnostic Technology, Inc. | 1979-10-11 | Traditional | PDF ↗ |
| K791772 | COUNTER-CHECK PLUS NORMAL, HIGH ABN. | Diagnostic Technology, Inc. | 1979-10-11 | Traditional | PDF ↗ |
| K791227 | PARA-7 | Streck Laboratories, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K791228 | PARA-8 | Streck Laboratories, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K791226 | PLATELET-CHEX PLUS | Streck Laboratories, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K791030 | HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL | Beckman Instruments, Inc. | 1979-06-22 | Traditional | PDF ↗ |
| K790826 | COAGULATION ARP | Helena Laboratories | 1979-05-31 | Traditional | PDF ↗ |
| K790415 | HCP-7 | Bioscientific | 1979-04-04 | Traditional | PDF ↗ |
| K790457 | HEMOGLOBIN CONTROLS | Data Medical Associates, Inc. | 1979-04-04 | Traditional | PDF ↗ |
| K790525 | HEMATROL S HEMATOLOGY CONTROLS | Fisher Scientific Co., LLC | 1979-04-03 | Traditional | PDF ↗ |
| K781969 | BLOOD, HEMATOLOGY REFERENCE CONTROL | Coulter Electronics, Inc. | 1979-01-03 | Traditional | PDF ↗ |
| K781786 | QUANTICEL HHR # L500 AND L501 | Bhp Diagnostix, Inc. | 1978-11-15 | Traditional | PDF ↗ |
| K781745 | QUANTICEL HHR, L531 AND L532 | Bhp Diagnostix, Inc. | 1978-11-15 | Traditional | PDF ↗ |
| K781573 | ABNORMAL HEMATOLOGY CONTROL UNASSAYED | Ortho Diagnostics, Inc. | 1978-10-17 | Traditional | PDF ↗ |
| K781572 | NORMAL HEMATOLOGY CONTROL UNASSAYED | Ortho Diagnostics, Inc. | 1978-10-17 | Traditional | PDF ↗ |
| K781247 | QUANTICEL-HRP | Bhp Diagnostix, Inc. | 1978-09-14 | Traditional | PDF ↗ |
| K780980 | PLATELET CONTROL | Bhp Diagnostix, Inc. | 1978-07-27 | Traditional | PDF ↗ |
| K781077 | CONTROL, HEMATOLOGY, CH-60 | Dade, Baxter Travenol Diagnostics, Inc. | 1978-07-27 | Traditional | PDF ↗ |
| K780835 | ARANTROL | Aranco Diagnostic Laboratories, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K780714 | PLATELET CONTROL | Bhp Diagnostix, Inc. | 1978-06-06 | Traditional | PDF ↗ |
| K780140 | CELL-CHEX | Streck Laboratories, Inc. | 1978-03-27 | Traditional | PDF ↗ |
| K772195 | HEMATOLOGY REFERENCE CONTROLS | R&D Systems, Inc. | 1978-02-03 | Traditional | PDF ↗ |
| K771753 | HEMATOLOGY REFERENCE CONTROL | Coulter Electronics, Inc. | 1977-11-28 | Traditional | PDF ↗ |
| K770384 | MNITROL HEMOTOL. REF. AND CONTROL | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-08 | Traditional | PDF ↗ |
| K770386 | LATELET, CONTROL, NORMAL & ABNORMAL | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-21 | Traditional | PDF ↗ |
| K770095 | PLATELET CONTROL, NORMAL & ABNORMAL | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-02-28 | Traditional | PDF ↗ |
| K770020 | PLATELET-CHEX-HUMAN | Streck Laboratories, Inc. | 1977-02-16 | Traditional | PDF ↗ |
| K760597 | BIOTROL-NORMAL | Boehringer Mannheim Corp. | 1976-10-08 | Traditional | PDF ↗ |
| K760596 | BIOTROL-ABNORMAL | Boehringer Mannheim Corp. | 1976-10-08 | Traditional | PDF ↗ |
| K760682 | 4C ABNORMAL LOW-HIGH (8 X 6 M1) | Coulter Electronics, Inc. | 1976-10-08 | Traditional | PDF ↗ |
| K760549 | PLATELET CONTROLS, NORMAL & ABNORMAL | Dade, Baxter Travenol Diagnostics, Inc. | 1976-10-08 | Traditional | PDF ↗ |
| K760162 | HEMATOLOGY CONTROL | Biological Corp. of America | 1976-08-04 | Traditional | PDF ↗ |
Product code JPK · Class II · Hematology. Data: openFDA.