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
841–864 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 17, 2000
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
K000398 · GGP
Shield Diagnostics, Ltd.
Hematology · 70d
Cleared Apr 07, 2000
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
K000527 · GIR
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Apr 07, 2000
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
K000528 · GIR
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Mar 28, 2000
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
K994194 · JBP
Cardiovascular Diagnostics, Inc.
Hematology · 106d
Cleared Mar 27, 2000
RETIC CHEX LINEARITY
K000115 · JPK
Streck Laboratories, Inc.
Hematology · 73d
Cleared Mar 24, 2000
THROMBOSTRATE CONTROL PLASMAS
K000679 · GGN
Pacific Hemostasis
Hematology · 24d
Cleared Mar 21, 2000
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K000239 · LCP
Genzyme Corp.
Hematology · 54d
Cleared Mar 15, 2000
ACL 9000 SYSTEM
K000053 · JPA
Instrumentation Laboratory CO
Hematology · 68d
Cleared Mar 03, 2000
CELL-CHEX
K000076 · GJR
Streck Laboratories, Inc.
Hematology · 53d
Cleared Mar 03, 2000
FIBRINOGEN CALIBRATOR KIT
K994341 · GFX
Dade Behring, Inc.
Hematology · 71d
Cleared Feb 18, 2000
PACIFIC HEMOSTASIS THROMBOPLASTIN D
K994100 · GJS
Pacific Hemostasis
Hematology · 77d
Cleared Feb 16, 2000
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
K993332 · GGC
Gradipore , Ltd.
Hematology · 135d
Cleared Feb 15, 2000
HMP CONTROLS (TAS) RAPIDPOINT
K994159 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 68d
Cleared Feb 10, 2000
I-STAT SYSTEM
K992571 · JBP
I-Stat Corp.
Hematology · 192d
Cleared Feb 03, 2000
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR...
K994006 · GJS
Avocet Medical, Inc.
Hematology · 71d
Cleared Feb 01, 2000
GTI-FVIII INHIBITOR ASSAY
K993553 · GGP
Genetic Testing Institute
Hematology · 104d
Cleared Jan 28, 2000
ADVANCED D-DIMER
K992957 · DAP
Dade Behring, Inc.
Hematology · 148d
Cleared Jan 14, 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO...
K992851 · JBP
Roche Diagnostics Corp.
Hematology · 143d
Cleared Jan 14, 2000
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST,...
K993519 · JOX
Cardiovascular Diagnostics, Inc.
Hematology · 88d
Cleared Jan 14, 2000
HEMOSITE TEST SYSTEM
K994073 · KHG
Gds Technology, LLC
Hematology · 43d
Cleared Jan 14, 2000
XE CHECK
K994388 · GLQ
Streck Laboratories, Inc.
Hematology · 17d
Cleared Jan 11, 2000
BEHRING COAGULATION SYSTEM (BCS)
K992959 · JPA
Dade Behring, Inc.
Hematology · 131d
Cleared Dec 21, 1999
HEMOCHEK-A1C SAMPLE COLLECTION KIT
K990899 · LCP
Osborn Group, Inc.
Hematology · 278d
Cleared Dec 21, 1999
GRADILEIDEN V TEST
K992456 · GGW
Gradipore , Ltd.
Hematology · 151d