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
2473–2496 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared May 07, 1984
PARAGON ACID HEMOGLOBIN REAGENT KIT
K834595 · GKA
Beckman Instruments, Inc.
Hematology · 129d
Cleared May 07, 1984
CENTRIFUGES
K840768 · JQC
Heraeus-Christ GmbH
Hematology · 74d
Cleared May 02, 1984
CELLTRAK-B
K834585 · FRZ
R&D Systems, Inc.
Hematology · 125d
Cleared May 02, 1984
FIBRINOGEN ASSAY KIT
K841020 · KQJ
Helena Laboratories
Hematology · 51d
Cleared May 02, 1984
ASSIGNED VALUE FOR MEAN PLATELET
K841239 · JPK
Coulter Electronics, Inc.
Hematology · 40d
Cleared May 02, 1984
COAGULATION CONTROL PLASMA LEVEL 1/2/3
K841461 · GGP
Diatech, Inc.
Hematology · 23d
Cleared May 01, 1984
DIA THROMBIN DIA PLASTIN
K840802 · GJS
Diatech, Inc.
Hematology · 68d
Cleared May 01, 1984
BIOSURE
K840848 · JJW
Helena Laboratories
Hematology · 67d
Cleared Apr 30, 1984
FACS ANALYZER
K840195 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 103d
Cleared Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA II
K840927 · GGP
Diatech, Inc.
Hematology · 59d
Cleared Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA VIII
K840928 · GGP
Diatech, Inc.
Hematology · 59d
Cleared Apr 30, 1984
CALCIUM CHLORIDE
K841522 · GGW
Diatech, Inc.
Hematology · 18d
Cleared Apr 25, 1984
DIA-H 1/2/3 & DIA-HT 1/2/3
K840801
Diatech, Inc.
Hematology · 62d
Cleared Apr 25, 1984
COAGULATION FACTOR V DEFICIENT SUBSTR
K841364 · GGP
American Dade
Hematology · 23d
Cleared Apr 23, 1984
REPTILASE-R HA35
K840210 · JCO
Wellcome Diagnostics
Hematology · 95d
Cleared Apr 23, 1984
DIACELIN
K840288 · GGN
Diatech, Inc.
Hematology · 90d
Cleared Apr 19, 1984
DADE HEMATOLOGY CALIBRATOR PLUS
K840010 · KRZ
American Dade
Hematology · 106d
Cleared Apr 19, 1984
KYOTEST UGK
K840829 · JIL
Kyoto Diagnostics, Inc.
Hematology · 55d
Cleared Apr 17, 1984
RUBAQUICK DIAGNOSTIC KIT
K834032 · GOL
Abbott Laboratories
Hematology · 147d
Cleared Apr 17, 1984
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 62d
Cleared Apr 17, 1984
HAEMOFUGE A. BIOFUGE A. & B
K840767 · JPI
Heraeus-Christ GmbH
Hematology · 54d
Cleared Apr 13, 1984
SICKLE-STAT HEMOGLOBIN S SCREEN KIT
K841272 · GHM
Clinical Technology Corp.
Hematology · 17d
Cleared Apr 05, 1984
RISTOCETIN COFACTOR ASSAY
K840329 · GGP
Helena Laboratories
Hematology · 71d
Cleared Apr 04, 1984
PARAMAX ACID PHOSPHATASE REAGENT
K840661 · CKB
American Dade
Hematology · 49d