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
1537–1560 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jan 11, 1993
DADE HEPZYME
K925452 · JBR
Baxter Diagnostics, Inc.
Hematology · 75d
Cleared Jan 07, 1993
MSI-HCT
K924926 · GLK
Medical Specialties, Inc.
Hematology · 99d
Cleared Dec 29, 1992
CD4 CYTOSPHERES KIT
K921279 · GKZ
Coulter Electronics, Inc.
Hematology · 287d
Cleared Dec 23, 1992
STACLOT LA TEST KIT
K923731 · GFO
American Bioproducts Co.
Hematology · 149d
Cleared Dec 21, 1992
CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION
K924509 · JPA
Behring Diagnostics, Inc.
Hematology · 108d
Cleared Dec 18, 1992
MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)
K924453 · JPA
Organon Teknika Corp.
Hematology · 107d
Cleared Dec 18, 1992
SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479
K924915 · JJY
Helena Laboratories
Hematology · 80d
Cleared Dec 15, 1992
LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
K911731 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 608d
Cleared Dec 07, 1992
COAMATE PROTEIN C CHROMOGENIC ASSAY
K922201 · GGP
Chromogenix AB
Hematology · 210d
Cleared Dec 07, 1992
NEOPLASTINE(R) CI KIT
K922565 · GJS
American Bioproducts Co.
Hematology · 189d
Cleared Dec 03, 1992
FIAGEN PROGESTERONE
K923410 · JLS
Cyberfluor, Inc.
Hematology · 146d
Cleared Dec 03, 1992
BICARBONATE
K924711 · KHS
Em Diagnostic Systems, Inc.
Hematology · 76d
Cleared Dec 01, 1992
BEHRING FIBRINTIMER A
K924124 · JPA
Behring Diagnostics, Inc.
Hematology · 106d
Cleared Dec 01, 1992
HEMOCARD(TM) CONTROL
K924173 · JCM
Isolab, Inc.
Hematology · 104d
Cleared Dec 01, 1992
CLOTTING FACTOR V DEFICIENT PLASMA
K924394 · GJT
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Dec 01, 1992
NEOTHROMITIN(R)
K924395 · GPO
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Dec 01, 1992
CLIBRATION PLASMAS
K924404 · GGN
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Dec 01, 1992
CONTROL PLASMA P
K924405 · GGC
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Dec 01, 1992
FILTERMATE UNIVERSAL HARVESTER
K924907 · JTC
Packard Instrument Co., Inc.
Hematology · 63d
Cleared Nov 17, 1992
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
K921681 · GGM
Isolab, Inc.
Hematology · 223d
Cleared Nov 16, 1992
ENZYGNOST F 1+2
K922934 · MIF
Behring Diagnostics, Inc.
Hematology · 151d
Cleared Nov 16, 1992
QC-CHEX
K923971 · JPK
Streck Laboratories, Inc.
Hematology · 102d
Cleared Nov 16, 1992
STANDARD HUMAN PLASMA
K924393 · JPA
Behring Diagnostics, Inc.
Hematology · 77d
Cleared Nov 16, 1992
GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT
K924496 · JPD
Drew Scientific , Ltd.
Hematology · 73d