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
721–744 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Feb 15, 2002
PACIFIC HEMOSTASIS REFERENCE EMULSION
K013397 · JIX
Fisher Diagnostics
Hematology · 123d
Cleared Feb 15, 2002
A1CNOW FOR RX HOME USE
K020234 · LCP
Metrika, Inc.
Hematology · 23d
Cleared Feb 15, 2002
A1CNOW FOR PROFESSIONAL USE
K020235 · LCP
Metrika, Inc.
Hematology · 23d
Cleared Feb 11, 2002
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST...
K020138 · KHG
Gds Technology
Hematology · 26d
Cleared Feb 08, 2002
CARESIDE APTT
K014028 · GFO
Careside Hemotology, Inc.
Hematology · 64d
Cleared Feb 06, 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · GGC
Sigma Diagnostics, Inc.
Hematology · 26d
Cleared Feb 06, 2002
R & D BODY FLUID CONTROL
K020229 · JPK
R&D Systems, Inc.
Hematology · 14d
Cleared Feb 01, 2002
BD VACUTAINER SAFETY COAGULATION TUBE
K013971 · JKA
Becton, Dickinson & CO
Hematology · 60d
Cleared Jan 24, 2002
HEMOCHRON JR. CITRATE APTT CUVETTE
K014008 · GFO
Itc, Inc.
Hematology · 50d
Cleared Jan 22, 2002
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
K013465 · LCP
Diabetes Technologies, Inc.
Hematology · 96d
Cleared Jan 22, 2002
R&D RET-LINE KIT
K013898 · JPK
R&D Systems, Inc.
Hematology · 60d
Cleared Jan 18, 2002
DADE THROMBOPLASTIN C PLUS
K013155 · GJS
Dade Behring, Inc.
Hematology · 119d
Cleared Jan 10, 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K013078 · JBP
Helena Laboratories
Hematology · 118d
Cleared Dec 26, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
K013549 · DAP
Sigma Diagnostics, Inc.
Hematology · 63d
Cleared Dec 13, 2001
IMMUNO-TROL LOW CELLS
K013842 · JPK
Beckman Coulter, Inc.
Hematology · 23d
Cleared Dec 10, 2001
REFERENCE CHECK, CATALOG NUMBER-RCN-10
K013708 · GIZ
Precision Biologic
Hematology · 32d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
K013544 · DAP
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
K013545 · DAP
Sigma Diagnostics, Inc.
Hematology · 22d
Cleared Nov 09, 2001
BCS SYSTEM
K013114 · JPA
Dade Behring, Inc.
Hematology · 52d
Cleared Nov 06, 2001
SICKLE-CHEX
K013316 · GHM
Streck Laboratories, Inc.
Hematology · 33d
Cleared Oct 26, 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
K012410 · LCP
Sigma Diagnostics, Inc.
Hematology · 88d
Cleared Oct 16, 2001
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
K011337 · JOZ
Accumetrics, Inc.
Hematology · 167d
Cleared Sep 28, 2001
PLATELETWORKS
K012723 · JOZ
Helena Laboratories
Hematology · 44d
Cleared Sep 28, 2001
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
K012934 · GKZ
Abbott Laboratories
Hematology · 28d