Hematology
4,194 FDA 510(k) clearances · Medical specialty
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
| Record | Firm | Date |
|---|---|---|
| SIRC (K842583) | Viromed Laboratories, Inc. | 1984-07-27 |
| HEK (K842584) | Viromed Laboratories, Inc. | 1984-07-27 |
| HISTOPAQUE-1077 (K842146) | Sigma Chemical Co. | 1984-07-27 |
| COULTER AUTOMATIC SAMPLE HANDLER (K842346) | Coulter Electronics, Inc. | 1984-07-27 |
| PARA-TEK (K841531) | Streck Laboratories, Inc. | 1984-07-27 |
| MINIMUM ESSENTIAL MED. M0769 W/WO (K842672) | Sigma Chemical Co. | 1984-07-20 |
| SICKLE CELL REAGENT SET (K842368) | Livonia Diagnostics, Inc. | 1984-07-20 |
| BASAL MED. EAGLE B8265, W/EARLS SALTS (K842671) | Sigma Chemical Co. | 1984-07-20 |
| MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII (K841708) | Meloy Laboratories, Inc. | 1984-07-19 |
| BOVINE THROMBIN, HUMAN THROMBIN (K841956) | Haemachem, Inc. | 1984-07-19 |
| DANAM ELEC. SA-1000 (K840649) | Danam Electronics | 1984-07-19 |
| BOVINE FACTOR XA-HUMAN FACTOR XA (K841957) | Haemachem, Inc. | 1984-07-19 |
| IDI ISOTONIC DILUENT (K842068) | Interscience Diagnostics, Inc. | 1984-07-02 |
| GENERAL DIAGNOSTICS PLATELET ANTIBODY (K841465) | General Diagnostics | 1984-07-02 |
| IDL-LYSING REAGENT (K842069) | Interscience Diagnostics, Inc. | 1984-07-02 |
| IMR-90-DIPLOID-HUMAN FETAL LUNG CELL (K841998) | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-27 |
| PARA 4 (K842017) | Streck Laboratories, Inc. | 1984-06-26 |
| HL-1, DEFINED SERUM FREE MEDIA (K841993) | Ventrex Laboratories, Inc. | 1984-06-25 |
| PRIMARY RABBITT KIDNEY CELL CULTURE (K842000) | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-22 |
| BGM CELL CULTURE AFRICAN GREEN MONKEY (K841999) | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-22 |
| HANKS BALANCED SALTS-HBSS H2387 (K842002) | Sigma Chemical Co. | 1984-06-22 |
| HEPARINOMETER (K834024) | Western Laboratories Corp. | 1984-06-11 |
| QUICK-COUNT PLUS 2 (K841504) | Seragen Diagnostics, Inc. | 1984-06-11 |
| TRANSPORTER VIRAL TRANSPORT MEDIUM (K840744) | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-07 |
| WI-38 (K841806) | Viromed Laboratories, Inc. | 1984-06-07 |
| HEPARIN COAGULATION CONTROL PLASMA 1- (K841462) | Diatech, Inc. | 1984-06-01 |
| DIA REPTIN (K841365) | Diatech, Inc. | 1984-06-01 |
| DIA FIBRIN (K841366) | Diatech, Inc. | 1984-06-01 |
| OWREN'S VERONAL BUFFERR (K841523) | Diatech, Inc. | 1984-06-01 |
| RETIC-SET (K841848) | R&D Systems, Inc. | 1984-05-31 |
| LYSING & HEMOGLOBIN REAGENT (K841800) | Reagent Laboratory, Inc. | 1984-05-31 |
| CYANOMETHEMOGLOBIN REAGENT (K841799) | Reagent Laboratory, Inc. | 1984-05-31 |
| HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM (K841021) | Hemotec, Inc. | 1984-05-25 |
| ULTRACLONE ECL-01-800 CELL LINE (K841337) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| ULTRACLONE ECL-01-1000 CELL LINE (K841341) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| ULTRA CLONE ECL-01-700 CELL LINE (K841339) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| ULTRACLONE ECL-01-400 CELL LINE (K841342) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| DULBECCO'S PHOSPHATE BUFFERED SALINE (K841744) | Sigma Chemical Co. | 1984-05-11 |
| ULTRACLONE ECL-01-100 CELL LINE (K841343) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| ULTRACLONE ECL-01-600 CELL LINE (K841338) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| ULTRACLONE ECL-01-200 CELL LINE (K841346) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| ULTRACLONE ECL-01-900 CELL LINE (K841340) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| ULTRACLONE ECL-01-500 CELL LINE (K841345) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| ULTRACLONE ECL-01-300 CELL LINE (K841344) | Earl-Clay Laboratories, Inc. | 1984-05-11 |
| RHESUS SV5/SV40 (K841665) | Viromed Laboratories, Inc. | 1984-05-07 |
| PARAGON ACID HEMOGLOBIN REAGENT KIT (K834595) | Beckman Instruments, Inc. | 1984-05-07 |
| RABBIT KIDNEY CELLS (K841666) | Viromed Laboratories, Inc. | 1984-05-07 |
| COAGULATION CONTROL PLASMA LEVEL 1/2/3 (K841461) | Diatech, Inc. | 1984-05-02 |
| FIBRINOGEN ASSAY KIT (K841020) | Helena Laboratories | 1984-05-02 |
| ASSIGNED VALUE FOR MEAN PLATELET (K841239) | Coulter Electronics, Inc. | 1984-05-02 |
| DIA THROMBIN DIA PLASTIN (K840802) | Diatech, Inc. | 1984-05-01 |
| FACTOR DEFICIENT SUBSTRATE PLASMA II (K840927) | Diatech, Inc. | 1984-04-30 |
| FACTOR DEFICIENT SUBSTRATE PLASMA VIII (K840928) | Diatech, Inc. | 1984-04-30 |
| FACS ANALYZER (K840195) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-04-30 |
| CALCIUM CHLORIDE (K841522) | Diatech, Inc. | 1984-04-30 |
| COAGULATION FACTOR V DEFICIENT SUBSTR (K841364) | American Dade | 1984-04-25 |
| REPTILASE-R HA35 (K840210) | Wellcome Diagnostics | 1984-04-23 |
| DIACELIN (K840288) | Diatech, Inc. | 1984-04-23 |
| DEAE-DEXTRAN IN PBS (K834116) | Bartels Immunodiagnostic Supplies, Inc. | 1984-04-20 |
| DADE HEMATOLOGY CALIBRATOR PLUS (K840010) | American Dade | 1984-04-19 |
| RAPID IMMUNO-ASSAY SYS (K840257) | Applied Polytechnology, Inc. | 1984-04-19 |
| HAEMOFUGE A. BIOFUGE A. & B (K840767) | Heraeus-Christ GmbH | 1984-04-17 |
| QBC CENTRIFUGAL HEMATOLOGY ANALYZ (K840658) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-04-17 |
| SICKLE-STAT HEMOGLOBIN S SCREEN KIT (K841272) | Clinical Technology Corp. | 1984-04-13 |
| RISTOCETIN COFACTOR ASSAY (K840329) | Helena Laboratories | 1984-04-05 |
| MANUAL BLOOD CELL COUNTING DEVICE (K841026) | Instrumentation Laboratory CO | 1984-04-04 |
| SICKLE HB ASSAY (K841170) | Isolab, Inc. | 1984-04-04 |
| S-CAL HEMATOLOGY CALIBRATOR (K840794) | Coulter Electronics, Inc. | 1984-04-04 |
| ERYTHROPOIETIN EIA (K833957) | Jcl Clinical Research Corp. | 1984-03-23 |
| HEMOGLOBIN REAGENT SET (K841057) | Medical Specialties, Inc. | 1984-03-23 |
| TISSUE CULTURE REFEEDING MEDIUM (K834113) | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-23 |
| PBS W/MG+2 & CA+2 (K834136) | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 |
| MCCOY CELLS (K834119) | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 |
| VERO CELLS (K834124) | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 |
| MRC-5 CELLS (K834126) | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 |
| LLC-MK2-RHESUS MONKEY KIDNEY CELLS (K834120) | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 |
| WI-38 HUMAN LUNG CELLS (K834123) | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 |
| HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN (K834117) | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 |
| PLT - 4 PLATELET (K840302) | R&D Systems, Inc. | 1984-03-12 |
| AMYLOID STAIN, CONGO RED HT 60 (K840798) | Sigma Chemical Co. | 1984-03-12 |
| TRI-COUNT 10 (K834371) | Hematology Marketing Assoc. | 1984-03-09 |
| UNITIZED HEMATOLOGY SET 65132/93 (K840477) | Emd Chemicals, Inc. | 1984-03-05 |
| SDI PREPAX DILUKIT HW (K840041) | Scientific Distributors, Inc. | 1984-03-05 |
| LYSE-TEC (K840289) | Medilab Corp. | 1984-03-05 |
| FIBRI-PREST AUTOMATE HA34 (K840211) | Wellcome Diagnostics | 1984-03-02 |
| CELL-DYN 100 WHOLE BLOOD PLATELET (K840170) | Abbott Diagnostics | 1984-03-02 |
| HEMOCCULT-C (K832311) | Menley & James Laboratories | 1984-02-27 |
| CAL-CHEX, A HEMATOLOGY CALIBRATOR (K840261) | Streck Laboratories, Inc. | 1984-02-21 |
| SEDIPLAST (K840500) | Precision Technology, Inc. | 1984-02-21 |
| PAPANICOLAOU STAIN SYS HT40 (K840054) | Sigma Chemical Co. | 1984-02-17 |
| QUICK-COUNT HEMATOLOGY REAGENT KIT (K833972) | Seragen Diagnostics, Inc. | 1984-02-17 |
| CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX (K834122) | Bartels Immunodiagnostic Supplies, Inc. | 1984-02-13 |
| PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ (K834372) | Diagnostic Technology, Inc. | 1984-02-10 |
| PRESERV GOMORI TRICHROME STAIN 125/500 (K840087) | Preventive Diagnostics Corp. | 1984-02-10 |
| PREPAX DILUKIT PLUS (K840038) | Scientific Distributors, Inc. | 1984-02-10 |
| COULTER COUNTER M2 (K834568) | Coulter Electronics, Inc. | 1984-02-10 |
| SDI PREPAX DILUKIT CT (K840043) | Scientific Distributors, Inc. | 1984-02-10 |
| RESOLVE-HB (K840011) | Isolab, Inc. | 1984-02-04 |
| COAGULATION FACTOR DEFICIENT PLASMA (K840114) | Medical Specialties Laboratories | 1984-02-04 |
| PROTOPATH FACTOR VIII ASSAY (K834051) | American Dade | 1984-02-04 |
Track Hematology automatically
Every clearance here is in the API, with alerts when new ones post.