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
1345–1368 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 06, 1995
ONYX
K943967 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Feb 14, 1995
THROMBOSCREEN THROMBOPLASTIN-DS
K940082 · GJS
Pacific Hemostasis
Hematology · 403d
Cleared Feb 06, 1995
SEDRATROL
K940430 · GJR
Medical Specialties Intl., Inc.
Hematology · 371d
Cleared Feb 03, 1995
SYSMEX K-4500
K943894 · GKZ
Sysmex Corp.
Hematology · 178d
Cleared Feb 03, 1995
ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
K944227 · GKP
Medical Laboratory Automation...
Hematology · 155d
Cleared Feb 01, 1995
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · GKP
American Bioproducts Co.
Hematology · 274d
Cleared Jan 25, 1995
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED,...
K945692 · GKZ
Dako Corp.
Hematology · 65d
Cleared Jan 24, 1995
PROTEIN C REAGENT, COAGULOMETRIC
K924425 · GGP
Behring Diagnostics, Inc.
Hematology · 875d
Cleared Jan 20, 1995
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
K942222 · JCM
Isolab, Inc.
Hematology · 259d
Cleared Jan 20, 1995
QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
K942276 · GIQ
Isolab, Inc.
Hematology · 255d
Cleared Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC VII
K935850 · GJT
Biomerieux Vitek, Inc.
Hematology · 405d
Cleared Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC X
K935851 · GJT
Biomerieux Vitek, Inc.
Hematology · 405d
Cleared Jan 11, 1995
RISTOCETIN COFACTOR ASSAY KIT
K945414 · GGP
Chrono-Log Corp.
Hematology · 65d
Cleared Dec 22, 1994
HEMOLAB
K931992 · GKP
Biomerieux Vitek, Inc.
Hematology · 608d
Cleared Dec 22, 1994
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
K934210 · GGP
Biomerieux Vitek, Inc.
Hematology · 479d
Cleared Dec 15, 1994
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
K943268 · KSA
Streck Laboratories, Inc.
Hematology · 161d
Cleared Dec 14, 1994
TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K941171 · GKZ
Miles, Inc.
Hematology · 275d
Cleared Dec 12, 1994
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
K943335 · JPK
R&D Systems, Inc.
Hematology · 153d
Cleared Dec 12, 1994
RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
K943336 · JPK
R&D Systems, Inc.
Hematology · 153d
Cleared Dec 08, 1994
COULTER FLOW SET
K944751 · JPK
Coulter Corp.
Hematology · 73d
Cleared Dec 02, 1994
APTT-ES
K935169 · GFO
Helena Laboratories
Hematology · 402d
Cleared Nov 22, 1994
DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA
K935307 · DDQ
Baxter Diagnostics, Inc.
Hematology · 385d
Cleared Nov 22, 1994
DADE INNOVIN II
K935702 · GJS
Baxter Diagnostics, Inc.
Hematology · 357d
Cleared Nov 21, 1994
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
K941872 · GGC
Helena Laboratories
Hematology · 217d