Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Hematology ×
3,297 results
1753–1776 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 22, 1990
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841 · KFF
Organon Teknika Corp.
Hematology · 62d
Cleared Oct 22, 1990
COAGULATION REFERENCE PLASMA, ABNORMAL
K904073 · GGC
Medi-Tech, Inc.
Hematology · 47d
Cleared Oct 04, 1990
CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY
K903665 · GKZ
Unipath , Ltd.
Hematology · 50d
Cleared Sep 25, 1990
COACUTE ANTITHROMBIN CHROMOGENIC ASSAY
K902393 · JBQ
Kabi Diagnostica
Hematology · 118d
Cleared Sep 17, 1990
STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES
K903698 · JPI
Statspin Technologies
Hematology · 33d
Cleared Sep 11, 1990
OPTIMATE HEMOGLOBIN A1C
K896830 · LCP
Heraeus Kulzer, Inc.
Hematology · 281d
Cleared Sep 10, 1990
CELL-DYN CALIBRATOR
K902892 · KRZ
Unipath , Ltd.
Hematology · 70d
Cleared Aug 27, 1990
MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT
K896918 · DEH
Dako Corp.
Hematology · 259d
Cleared Aug 22, 1990
TRI-COUNT 16
K902389 · JCN
Hematronix, Inc.
Hematology · 84d
Cleared Aug 22, 1990
CELL-DYN 3000 CONTROL
K902391 · JCN
Unipath , Ltd.
Hematology · 84d
Cleared Aug 22, 1990
LYMPHO SEP(TM)
K902445 · JCF
Icn Biomedicals, Inc.
Hematology · 82d
Cleared Aug 22, 1990
EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)
K902639 · GGT
Incstar Corp.
Hematology · 69d
Cleared Aug 10, 1990
ACS ONE-STAGE PROTHROMBIN TIME REAGENT
K902468 · GJS
Analytical Control Systems, Inc.
Hematology · 67d
Cleared Aug 09, 1990
BIOCLOT C KIT
K902528 · GGP
Biopool AB
Hematology · 65d
Cleared Aug 09, 1990
SPECTROLYSE ATIII KIT
K902530 · JBQ
Biopool AB
Hematology · 65d
Cleared Aug 09, 1990
BIOPOOL PROTEIN C EID KIT AND BULK PLATES
K902566 · GGP
Biopool AB
Hematology · 59d
Cleared Aug 06, 1990
BECKMAN ANTITHROMBIN III REAGENT KIT
K901977 · JBQ
Beckman Instruments, Inc.
Hematology · 96d
Cleared Aug 06, 1990
ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K902556 · GFO
Analytical Control Systems, Inc.
Hematology · 59d
Cleared Aug 01, 1990
MODIFIED COAG-1 PT TEST CARD
K903019 · GJS
Cardiovascular Diagnostic Services
Hematology · 21d
Cleared Jul 27, 1990
HEMA-SCREEN
K902360 · KHE
Immunostics Co., Inc.
Hematology · 59d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL I
K902361 · GGN
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL II
K902362 · GGN
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 26, 1990
COAGULATION CONTROL, LEVEL III
K902363 · GGN
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 24, 1990
BEHRING CHROMOTIMER
K901829 · JJQ
Behring Diagnostics, Inc.
Hematology · 91d