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
745–768 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Sep 21, 2001
SQA, SPERM QUALITY ANALYZER
K012352 · POV
Medical Electronic Systems, LLC
Hematology · 58d
Cleared Sep 21, 2001
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
K012904 · GKZ
Bayer Diagnostics Corp.
Hematology · 23d
Cleared Sep 18, 2001
G7 AUTOMATED HPLC ANALYZER
K011434 · LCP
Tosoh Medics, Inc.
Hematology · 131d
Cleared Sep 18, 2001
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2,...
K012722 · GGN
Bio-Rad
Hematology · 34d
Cleared Sep 18, 2001
HEMOSIL RECOMBI PLASTIN
K012768 · GJS
Instrumentation Laboratory CO
Hematology · 32d
Cleared Sep 14, 2001
ACTICLOT PROTEIN S, MODEL 843L
K012386 · GGP
American Diagnostica, Inc.
Hematology · 49d
Cleared Sep 07, 2001
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
K010750 · GGN
Fisher Diagnostics
Hematology · 178d
Cleared Aug 21, 2001
K-ASSAY D-DIMER CONTROLS
K012422 · GGC
Kamiya Biomedical Co.
Hematology · 22d
Cleared Aug 15, 2001
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
K011679 · POV
Embryotech Laboratories, Inc.
Hematology · 77d
Cleared Aug 09, 2001
BCT SYSTEM
K011665 · JPA
Dade Behring, Inc.
Hematology · 71d
Cleared Jul 26, 2001
MODIFICATION TO THERMAL ANGEL
K012031 · BSB
Estill Medical Technologies, Inc.
Hematology · 28d
Cleared Jul 20, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
K011235 · JPA
Dade Behring, Inc.
Hematology · 88d
Cleared Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
K010748 · LCP
Beckman Coulter, Inc.
Hematology · 119d
Cleared Jul 09, 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K011342 · GKZ
Beckman Coulter, Inc.
Hematology · 68d
Cleared Jul 02, 2001
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
K010599 · GJS
International Technidyne Corp.
Hematology · 124d
Cleared Jun 26, 2001
PARA 5X
K011410 · JPK
Streck Laboratories, Inc.
Hematology · 49d
Cleared Jun 25, 2001
IL TEST PROS
K011424 · GGP
Instrumentation Laboratory CO
Hematology · 47d
Cleared Jun 21, 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA...
K002885 · JOZ
Dade Behring, Inc.
Hematology · 279d
Cleared Jun 21, 2001
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
K011389 · JCM
Canterbury Health Laboratories
Hematology · 45d
Cleared Jun 07, 2001
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
K010455 · KFF
Diagnostica-Stago
Hematology · 129d
Cleared Jun 06, 2001
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
K010193 · KFF
International Technidyne Corp.
Hematology · 135d
Cleared Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
K010953 · GKZ
Abbott Laboratories
Hematology · 68d
Cleared Jun 06, 2001
STA-LIATEST FREE PROTEIN S TEST KIT
K010963 · GGP
Diagnostica Stago, Inc.
Hematology · 68d
Cleared May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
K011143 · GHH
Roche Diagnostics Corp.
Hematology · 46d