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
1489–1512 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jul 06, 1993
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
K931465 · JBD
Helena Laboratories
Hematology · 104d
Cleared Jun 28, 1993
BERICHROM HEPARIN
K925200 · KFF
Behring Diagnostics, Inc.
Hematology · 255d
Cleared Jun 25, 1993
PREDICTA ERYTHROPOIETIN KIT
K926390 · GGT
Genzyme Corp.
Hematology · 185d
Cleared Jun 22, 1993
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
K930685 · GKL
Heraeus Kulzer, Inc.
Hematology · 132d
Cleared Jun 18, 1993
IL MCL-2 COAGULATION ANALYZER
K924098 · GKP
Instrumentation Laboratory CO
Hematology · 309d
Cleared Jun 18, 1993
CHECKPOINT
K931947 · JPK
Medical Specialties, Inc.
Hematology · 60d
Cleared Jun 08, 1993
CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
K924400 · GJT
Behring Diagnostics, Inc.
Hematology · 281d
Cleared Jun 02, 1993
VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
K926422 · GGJ
Syva Co.
Hematology · 161d
Cleared May 21, 1993
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
K924396 · GJT
Behring Diagnostics, Inc.
Hematology · 263d
Cleared May 20, 1993
FACTOR CONTROL [P]
K930959 · GGC
American Bioproducts Co.
Hematology · 85d
Cleared May 18, 1993
BIOMERIEUX HEMOLAB FIBRINOMAT
K925494 · GIS
Biomerieux Vitek, Inc.
Hematology · 197d
Cleared May 14, 1993
TEST THROMBIN
K930157 · GJA
Behring Diagnostics, Inc.
Hematology · 121d
Cleared May 11, 1993
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
K930148 · GKZ
Heraeus Kulzer, Inc.
Hematology · 119d
Cleared May 11, 1993
THROMBOPLATIN-M WITH CALCIUM
K930212 · GJS
Sigma Diagnostics, Inc.
Hematology · 116d
Cleared May 07, 1993
CRIT-LINE
K924167 · JPI
Noninvasive Medical Technology Corp.
Hematology · 261d
Cleared Apr 27, 1993
ACS APCT REAGENT, MODIFIED
K926012 · GFO
Analytical Control Systems, Inc.
Hematology · 158d
Cleared Apr 27, 1993
COAG-CONTROL
K930923 · GGC
American Bioproducts Co.
Hematology · 63d
Cleared Apr 20, 1993
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
K930849 · JPA
Organon Teknika Corp.
Hematology · 61d
Cleared Apr 12, 1993
IL TEST(TM) PROTEIN S
K930327 · GGP
Instrumentation Laboratory CO
Hematology · 80d
Cleared Apr 08, 1993
HEMOCARD HEMOGLOBIN E
K930070 · CKA
Isolab, Inc.
Hematology · 92d
Cleared Apr 06, 1993
LUCOR CONFIRMATORY REAGENT
K922156 · GIR
Gradipore , Ltd.
Hematology · 334d
Cleared Apr 06, 1993
LUPO-TEST REGEANT
K922326 · GIR
Graoipore , Ltd.
Hematology · 330d
Cleared Apr 05, 1993
COULTER RETIC-C CELL CONTROL
K930119 · JPK
Coulter Electronics, Inc.
Hematology · 83d
Cleared Mar 29, 1993
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
K926469 · LCP
Bio-Rad
Hematology · 91d