FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×
3,294 results
2569–2592 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 20, 1983
PLATELET AGGREGATION REAGENT SET
K832428 · GHR
Helena Laboratories
Hematology · 90d
Cleared Oct 20, 1983
TRI-COUNT 7
K833130 · JPK
Hematology Marketing Assoc.
Hematology · 37d
Cleared Oct 19, 1983
HEMACOMP 7 OR HEMATIL 7
K832890 · GKL
Texas Intl. Laboratories, Inc.
Hematology · 54d
Cleared Oct 14, 1983
BLOOD GAS QUALITY CONTROL SOFT-86000F
K831574 · JQP
Computermate, Inc.
Hematology · 151d
Cleared Oct 14, 1983
HEMOCHRON THROMBOCHRONOMETER
K832189 · JBP
International Technidyne Corp.
Hematology · 98d
Cleared Sep 29, 1983
MIDAS 6000 AUTOMATIC STAINER
K832994 · KPA
Innovative Medical Systems, Inc.
Hematology · 27d
Cleared Sep 26, 1983
SUPERJET BTD BLEEDING TIME DEVICE DISP
K830001 · FMK
Medprobe Laboratories
Hematology · 266d
Cleared Sep 26, 1983
CELL-DYN 900 HEMATOLOGY ANALYZER
K832643 · GKL
Abbott Diagnostics
Hematology · 53d
Cleared Sep 12, 1983
TRUST RPR CARD TEST #65144
K832479 · GMQ
Emd Chemicals, Inc.
Hematology · 48d
Cleared Sep 12, 1983
TRUST RPR TITRATION CARD TEST #65145
K832480 · GMQ
Emd Chemicals, Inc.
Hematology · 48d
Cleared Sep 12, 1983
TECHNICON H6000 SYSTEM
K832627 · GKL
Technicon Instruments Corp.
Hematology · 39d
Cleared Sep 01, 1983
PHADEBACT STREP POSITIVE CONTROLS
K832248 · GTY
Pharmacia, Inc.
Hematology · 52d
Cleared Sep 01, 1983
HEMOGLOBINOMETER
K832288 · KMG
Mallinckrodt Critical Care
Hematology · 50d
Cleared Sep 01, 1983
FACS ANALYZER
K832420 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 41d
Cleared Aug 31, 1983
MONOJET SAMPLETTE ADAPTERS
K832578 · GIO
Sherwood Medical Co.
Hematology · 29d
Cleared Aug 26, 1983
COATEST FACTOR X
K832114 · GGP
Kabivitrum, Inc.
Hematology · 57d
Cleared Aug 24, 1983
TITAN GEL GLYCO-HEME SYSTEM
K832087 · LCP
Helena Laboratories
Hematology · 57d
Cleared Aug 16, 1983
FITKIT I CHECKUP KIT
K830340 · CDM
Boditestor
Hematology · 195d
Cleared Aug 12, 1983
AMERI CLEAR
K832011 · KEM
Stephens Scientific
Hematology · 50d
Cleared Aug 12, 1983
LYSING REAGENT
K832182 · GGK
Omega Medical Diagnostics
Hematology · 36d
Cleared Aug 12, 1983
ORTHO ABNORMAL COAGULATION LEVEL I/II
K832225 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 35d
Cleared Aug 12, 1983
RABBIT ANTI-HUMAN ANTITHROMBIN III
K832268 · JBQ
Gelco Diagnostics, Inc.
Hematology · 43d
Cleared Aug 01, 1983
CLINOVATIVE II DIAGNOSTIC KIT
K831837 · LCP
Pierce Chemical Co.
Hematology · 55d
Cleared Jul 28, 1983
SODIUM HYPOCHLORITE 7%
K831619 · PPM
Omega Medical Diagnostics
Hematology · 70d