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
1153–1176 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 14, 1996
SICKLE-2000
K955719 · GIQ
Medicus Technologies, Inc.
Hematology · 240d
Cleared Aug 14, 1996
SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
K960871 · JBQ
Medical Diagnostic Technologies, Inc.
Hematology · 163d
Cleared Aug 13, 1996
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
K961814 · GIZ
Cardiovascular Diagnostics, Inc.
Hematology · 95d
Cleared Aug 12, 1996
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749 · JBP
International Technidyne Corp.
Hematology · 171d
Cleared Jul 31, 1996
CHROMOLIZE TPA ASSAY KIT
K962489 · GGP
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Jul 29, 1996
N/T PROTEIN CONTROL PY
K962407 · GIL
Behring Diagnostics, Inc.
Hematology · 38d
Cleared Jul 23, 1996
STA - VWF CONTROL [N]+[P] KIT
K962674 · GGN
American Bioproducts Co.
Hematology · 14d
Cleared Jul 22, 1996
COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
K961278 · GKZ
Coulter Corp.
Hematology · 110d
Cleared Jul 16, 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE
K961701 · GKZ
Dako Corp.
Hematology · 75d
Cleared Jul 16, 1996
N PROTEIN STANDARD PY
K962410 · JIX
Behring Diagnostics, Inc.
Hematology · 25d
Cleared Jul 15, 1996
R&D RETIC-PG HEMATOLOGY CONTROL
K961673 · JPK
R&D Systems, Inc.
Hematology · 75d
Cleared Jul 10, 1996
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · GKP
American Bioproducts Co.
Hematology · 77d
Cleared Jul 05, 1996
SPUNCRIT (MODEL DRC-40)
K961803 · GKG
Micro Diagnostics Corp.
Hematology · 57d
Cleared Jul 01, 1996
SAS SICKLE CELL TEST
K960947 · GHM
Sa Scientific, Inc.
Hematology · 115d
Cleared Jul 01, 1996
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
K961610 · GKZ
R&D Systems, Inc.
Hematology · 67d
Cleared Jun 28, 1996
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
K961938 · GJS
Nova Biomedical Corp.
Hematology · 39d
Cleared Jun 26, 1996
THERMACYL BLOOD/FLUID WARMER
K953741 · BSB
Baxter Healthcare Corp
Hematology · 321d
Cleared Jun 20, 1996
PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
K954202 · JPA
Medtronic Hemotec, Inc.
Hematology · 287d
Cleared Jun 14, 1996
MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
K960531 · GKZ
Dako Corp.
Hematology · 128d
Cleared Jun 14, 1996
MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE
K961435 · GKZ
Dako Corp.
Hematology · 60d
Cleared Jun 13, 1996
HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS...
K955087 · LCP
Bayer Corp.
Hematology · 219d
Cleared Jun 07, 1996
FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS
K961623 · GKZ
Becton Dickinson Monoclonal Center
Hematology · 42d
Cleared Jun 05, 1996
MEDICOUNT DEKA HEMATOLOGY ANALYZER
K942525 · GKZ
Cea America Corp.
Hematology · 740d
Cleared Jun 05, 1996
TINTELIZE PAI-1 KIT
K960438 · GGP
Medical Diagnostic Technologies, Inc.
Hematology · 126d