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
1705–1728 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 13, 1991
ANEMIA I, II
K911984 · JJY
Ciba Corning Diagnostics Corp.
Hematology · 41d
Cleared Jun 11, 1991
DADE(R) PROTEIN C ABNORMAL CONTRAL
K911885 · GGC
Baxter Healthcare Corp
Hematology · 43d
Cleared Jun 10, 1991
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K911347 · JCM
Bio-Rad
Hematology · 75d
Cleared May 28, 1991
STAK-CHEX
K911582 · JCN
Streck Laboratories, Inc.
Hematology · 50d
Cleared May 20, 1991
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
K904253 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 248d
Cleared May 20, 1991
EPINEPHRINE REAGENT, CAT. NO. 5367
K910680 · GHR
Helena Laboratories
Hematology · 94d
Cleared May 20, 1991
COLLAGEN REAGENT CAT. NO. 5368
K910706 · GHR
Helena Laboratories
Hematology · 89d
Cleared May 20, 1991
ADP REAGENT
K910800 · GHR
Helena Laboratories
Hematology · 84d
Cleared May 10, 1991
HITT BY HEMOCHRON(R)
K910181 · KFF
International Technidyne Corp.
Hematology · 114d
Cleared May 07, 1991
GENESIS I AUTOMATED CELL COUNTER
K910679 · GKL
Alicia Diagnostics, Inc.
Hematology · 81d
Cleared May 07, 1991
QBC AUTOREADER
K910834 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 69d
Cleared May 06, 1991
FHT (FECAL HEME TEST)
K905782 · KHE
Aerscher, Inc.
Hematology · 136d
Cleared Apr 29, 1991
ABS CADKIT
K910636 · GIS
Panbio, Inc.
Hematology · 75d
Cleared Apr 29, 1991
HEPARIN CONTROLS, HIGH AND LOW
K910741 · KFF
Sigma Diagnostics, Inc.
Hematology · 67d
Cleared Apr 16, 1991
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
K905807 · GJS
Helena Laboratories
Hematology · 110d
Cleared Apr 15, 1991
HEMOCARD-AS
K910430 · GHM
Isolab, Inc.
Hematology · 73d
Cleared Apr 12, 1991
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
K905643 · GHH
Agen Biomedical , Ltd.
Hematology · 116d
Cleared Apr 12, 1991
DANAM DATACELL-18
K910283 · GKZ
Danam Electronics
Hematology · 79d
Cleared Apr 03, 1991
FLOW CYTOMETRY FITC/PE COMPENSATION KIT
K910255 · JIW
Sigma Diagnostics, Inc.
Hematology · 71d
Cleared Mar 19, 1991
PLATELET AGGREGATION REAGENTS
K910286 · GHR
Medical Diagnostic Technologies, Inc.
Hematology · 56d
Cleared Mar 11, 1991
HEMOCARD CONTROL
K910431 · JCM
Isolab, Inc.
Hematology · 38d
Cleared Feb 27, 1991
HELENA THROMBOPLASTIN REAGENT, MODIFICATION
K905857 · GJS
Helena Laboratories
Hematology · 75d
Cleared Feb 26, 1991
DADE PROTEIN C CLOTTING ASSAY
K903468 · GGP
Baxter Healthcare Corp
Hematology · 209d
Cleared Feb 26, 1991
PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
K910105 · GFT
International Technidyne Corp.
Hematology · 54d