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
865–888 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Dec 21, 1999
PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
K994045 · LCP
Primus Corp.
Hematology · 22d
Cleared Dec 20, 1999
POLLER CALIBRANTS
K991439 · GGN
European Concerted Action on...
Hematology · 238d
Cleared Dec 20, 1999
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA...
K992531 · JOZ
Accumetrics, Inc.
Hematology · 145d
Cleared Dec 20, 1999
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
K993375 · KRX
Clinical Diagnostic Solutions, Inc.
Hematology · 74d
Cleared Dec 14, 1999
SIMPLIFY D-DIMER, MODEL DCGK1
K993276 · GHH
Agen Biomedical , Ltd.
Hematology · 75d
Cleared Dec 07, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K993299 · GKP
Dade Behring, Inc.
Hematology · 67d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · GFO
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · GFO
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Dec 06, 1999
COLON ALERT TEST
K992759 · KHE
Immunostics Inc.,
Hematology · 111d
Cleared Dec 06, 1999
K-ASSAY FIBRINOGEN
K993482 · GIS
Kamiya Biomedical Co.
Hematology · 53d
Cleared Dec 02, 1999
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1...
K993104 · GLY
Nova Biomedical Corp.
Hematology · 77d
Cleared Dec 01, 1999
PLATELETWORKS
K990398 · JOZ
Array Medical, Inc.
Hematology · 295d
Cleared Nov 30, 1999
RETIC-QUINOX
K993496 · JPK
Hematronix, Inc.
Hematology · 46d
Cleared Nov 30, 1999
PARA TECH PLUS RETICS
K993825 · JCN
Streck Laboratories, Inc.
Hematology · 18d
Cleared Nov 26, 1999
SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
K991850 · LCP
Biosafe Laboratories, Inc.
Hematology · 178d
Cleared Nov 26, 1999
CD-CHEX CD 34
K993126 · GGL
Streck Laboratories, Inc.
Hematology · 67d
Cleared Nov 22, 1999
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · GGN
Medical Analysis Systems, Inc.
Hematology · 91d
Cleared Nov 22, 1999
STAK-CHEX PLUS RETICS
K992887 · GLQ
Streck Laboratories, Inc.
Hematology · 87d
Cleared Nov 18, 1999
AVOCET ACUSURE SYSTEM
K991286 · GJS
Avocet Medical, Inc.
Hematology · 217d
Cleared Nov 12, 1999
PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
K992921 · LCP
Primus Corp.
Hematology · 74d
Cleared Nov 12, 1999
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · GGM
R&D Systems, Inc.
Hematology · 39d
Cleared Nov 09, 1999
SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
K992875 · GKZ
Sysmex Corp.
Hematology · 75d
Cleared Nov 09, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K993174 · GKP
Dade Behring, Inc.
Hematology · 48d
Cleared Nov 02, 1999
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO...
K992492 · GJS
Roche Diagnostics Corp.
Hematology · 99d