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
985–1008 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 07, 1998
MICRO21 WITH URINE SEDIMENT ANALYSIS
K982301 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 37d
Cleared Jul 30, 1998
HEPTRAC ELECTRONIC QUALITY CONTROL
K981815 · JPA
Medtronic Blood Management
Hematology · 69d
Cleared Jul 22, 1998
DADE INNOVIN
K974343 · GJS
Dade Intl., Inc.
Hematology · 245d
Cleared Jul 22, 1998
DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
K980635 · GKZ
Dako Corp.
Hematology · 153d
Cleared Jul 20, 1998
STATUSFLOW
K982231 · GKZ
R&D Systems, Inc.
Hematology · 25d
Cleared Jul 07, 1998
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
K974799 · JPA
International Technidyne Corp.
Hematology · 197d
Cleared Jul 07, 1998
IL TEST PT-FIBRINOGEN RECOMBINANT
K981479 · GJS
Instrumentation Laboratory CO
Hematology · 74d
Cleared Jul 06, 1998
VIGIL HEMOGLOBIN (HBALC) CONTROLS
K982022 · JJX
Beckman Coulter, Inc.
Hematology · 27d
Cleared Jun 29, 1998
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
K981342 · GKZ
Abbott Laboratories
Hematology · 77d
Cleared Jun 15, 1998
AIC - CHEK (HBAIC-I)
K973365 · LCP
Express-Med, Inc.
Hematology · 280d
Cleared Jun 15, 1998
I-STAT COAGULATION CONTROL SET
K981752 · GGN
Biopool Intl., Inc.
Hematology · 28d
Cleared Jun 09, 1998
WINSCAN AUTOMATED IMAGING SYSTEM
K980375 · JOY
Applied Imaging Corp.
Hematology · 130d
Cleared May 26, 1998
DIMERTEST LATEX ASSAY
K974596 · DAP
Agen Biomedical , Ltd.
Hematology · 168d
Cleared May 26, 1998
IL TEST PLASMINOGEN
K981200 · GGP
Instrumentation Laboratory CO
Hematology · 54d
Cleared May 26, 1998
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
K981206 · GKP
Cardiovascular Diagnostics, Inc.
Hematology · 55d
Cleared May 22, 1998
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
K980858 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 78d
Cleared May 13, 1998
ACCU-CHEK A1C HEMOGLOBIN TEST
K974491 · LCP
Boehringer Mannheim Corp.
Hematology · 166d
Cleared May 12, 1998
COLOSCREEN-ES
K980671 · KHE
Helena Laboratories
Hematology · 81d
Cleared May 12, 1998
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
K981426 · GKF
Nova Biomedical Corp.
Hematology · 26d
Cleared May 12, 1998
STAT PROFILE M ANALYZER
K981427 · GKF
Nova Biomedical Corp.
Hematology · 26d
Cleared May 01, 1998
COAMATIC PLASMINOGEN
K974711 · GGP
Instrumentation Laboratory CO
Hematology · 135d
Cleared Apr 30, 1998
BAIR HUGGER BLOOD/FLUID WARMER
K973741 · BSB
Augustine Medical, Inc.
Hematology · 211d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254 · GGN
Sigma Diagnostics, Inc.
Hematology · 23d