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
1033–1056 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Nov 17, 1997
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST...
K970505 · JOZ
Dade Intl., Inc.
Hematology · 280d
Cleared Nov 07, 1997
MICRO21 WITH WBC ESTIMATE
K973050 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 84d
Cleared Nov 04, 1997
IL TEST D-DIMER
K972696 · DAP
Instrumentation Laboratory CO
Hematology · 109d
Cleared Nov 04, 1997
IL TEST APTT-SP
K973306 · GFO
Instrumentation Laboratory CO
Hematology · 62d
Cleared Oct 31, 1997
ACCUCOLOR HIGH CALIBRATOR (A3089)
K973274 · GIZ
Sigma Diagnostics, Inc.
Hematology · 59d
Cleared Oct 29, 1997
COULTER AC.T DIFF ANALYZER
K973634 · GKZ
Coulter Corp.
Hematology · 35d
Cleared Oct 22, 1997
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
K970742 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 236d
Cleared Oct 20, 1997
N-ASSAY TIA PLASMINOGEN TEST KIT
K971985 · GGP
Crestat Diagnostics, Inc.
Hematology · 144d
Cleared Oct 20, 1997
N-ASSAY TIA ANTITHROMBIN III TEST KIT
K972257 · DDQ
Crestat Diagnostics, Inc.
Hematology · 125d
Cleared Oct 20, 1997
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
K972260 · JPA
Sigma Diagnostics, Inc.
Hematology · 125d
Cleared Oct 20, 1997
HEMAPROMPT
K972763 · KHE
Aerscher Diagnostics
Hematology · 88d
Cleared Oct 10, 1997
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
K972796 · GJS
Sigma Diagnostics, Inc.
Hematology · 74d
Cleared Oct 09, 1997
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858 · KQJ
Sigma Diagnostics, Inc.
Hematology · 142d
Cleared Oct 06, 1997
REAADS PROTEIN C ANTIGEN TEST KIT
K972342 · GGP
Reaads Medical Products, Inc.
Hematology · 104d
Cleared Oct 01, 1997
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND...
K971935 · JBP
B & D Corp.
Hematology · 127d
Cleared Sep 25, 1997
AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
K964406 · JWO
Daxor Corporation
Hematology · 325d
Cleared Sep 25, 1997
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
K972265 · LCP
Tosoh Medics, Inc.
Hematology · 100d
Cleared Sep 25, 1997
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
K973143 · GGP
Universal Reagents, Inc.
Hematology · 34d
Cleared Sep 22, 1997
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
K972969 · GIO
Innovative Medical Technologies, Inc.
Hematology · 42d
Cleared Sep 16, 1997
MICRO21 WITH CEREBROSPINAL FLUID
K971470 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 147d
Cleared Sep 16, 1997
ABBOTT CELL-DYN 3200 SYSTEM
K972354 · GKZ
Abbott Laboratories
Hematology · 84d
Cleared Sep 09, 1997
OPUS D-DIMER
K972316 · GHH
Behring Diagnostics, Inc.
Hematology · 81d
Cleared Sep 05, 1997
EZCHEK/HBA BLOOD COLLECTION KIT
K971919 · LCP
Flexsite Diagnostics, Inc.
Hematology · 105d
Cleared Aug 29, 1997
CRYO CHECK INR VALIDATION SET
K971219 · GGN
Precision Biologicals, Inc.
Hematology · 149d