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
1969–1992 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Dec 20, 1988
ERYTHROPOIETIN ENZYME IMMUNOASSAY
K882686 · GGT
Amgen, Inc.
Hematology · 173d
Cleared Dec 20, 1988
TURBOX ANTITHROMBIN III
K884144 · JBQ
Unipath , Ltd.
Hematology · 81d
Cleared Dec 20, 1988
TURBOX FIBRINOGEN
K884179 · KQJ
Unipath , Ltd.
Hematology · 81d
Cleared Dec 13, 1988
COATEST PROTEIN C
K884058 · GGP
Kabivitrum, Inc.
Hematology · 78d
Cleared Dec 05, 1988
SYSMEX NE-8000
K883997 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 76d
Cleared Dec 05, 1988
HEMAT 12
K884006 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 75d
Cleared Dec 01, 1988
TENDERFOOT
K883968 · FMK
International Technidyne Corp.
Hematology · 72d
Cleared Dec 01, 1988
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
K884623 · GIO
Safe-Tec Clinical Products, Inc.
Hematology · 27d
Cleared Nov 30, 1988
H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
K883177 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 126d
Cleared Nov 30, 1988
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
K883836 · GGK
Coulter Immunology
Hematology · 79d
Cleared Nov 23, 1988
BERICHROM(R) ANTITHROMBIN III
K883662 · JBQ
Behring Diagnostics, Inc.
Hematology · 89d
Cleared Nov 22, 1988
GHB SAMPLE PAPER
K880673 · LCP
Isolab, Inc.
Hematology · 277d
Cleared Nov 22, 1988
MSI-CAL 7
K883703 · KRZ
Medical Specialties, Inc.
Hematology · 84d
Cleared Nov 22, 1988
MSI-CAL 16
K883850 · KRZ
Medical Specialties, Inc.
Hematology · 84d
Cleared Nov 22, 1988
MSI-CAL 8
K883851 · KRZ
Medical Specialties, Inc.
Hematology · 84d
Cleared Nov 01, 1988
ORTHO FACTOR XII DEFICIENT PLASMA
K883688 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO OWREN'S BUFFER
K883689 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR X DEFICIENT PLASMA
K883690 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR XI DEFICIENT PLASMA
K883691 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR VII DEFICIENT PLASMA
K883692 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Oct 31, 1988
IMMUNOCCULT-LXI
K883432 · KHE
Intl. Immunoassay Laboratories, Inc.
Hematology · 77d
Cleared Oct 31, 1988
KD 0.1 M SODIUM CITRATE SOLUTION
K883635 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
KD 0.02 M CALCIUM CHLORIDE SOLUTION
K883637 · JPA
King Diagnostics, Inc.
Hematology · 67d
Cleared Oct 31, 1988
KD ONE-STAGE PROTHROMBIN TIME TEST
K883640 · JPA
King Diagnostics, Inc.
Hematology · 67d