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
1393–1416 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 16, 1994
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
K942209 · JCN
Bio-Rad
Hematology · 42d
Cleared Jun 06, 1994
CD-CHEX CD4 LOW
K931825 · GGL
Streck Laboratories, Inc.
Hematology · 426d
Cleared May 18, 1994
MICROCOAGULATION PROTHROMBIN TIME TEST
K940432 · GJS
International Technidyne Corp.
Hematology · 107d
Cleared May 17, 1994
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
K935308 · JBQ
Sigma Diagnostics, Inc.
Hematology · 196d
Cleared May 11, 1994
JR. MICROCOAGULATION SYSTEM
K940401 · JPA
International Technidyne Corp.
Hematology · 104d
Cleared May 09, 1994
GLYCATED PROTEIN CALIBRATORS
K940008 · JIS
Primus Corp.
Hematology · 125d
Cleared May 06, 1994
HEMOLAB HEPARICHROM ASSAY
K934274 · KFF
Biomerieux Vitek, Inc.
Hematology · 248d
Cleared May 04, 1994
ANTITHROMBIN III CHROMOGENIC ASSAY
K936196 · JBQ
Baxter Diagnostics, Inc.
Hematology · 126d
Cleared May 02, 1994
COATEST(R) ANTITHROMBIN III, MODIFICATION
K931420 · JBQ
Kabi Pharmacia Hepar, Inc.
Hematology · 419d
Cleared May 02, 1994
SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER
K936023 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 138d
Cleared Apr 26, 1994
GLYCATED PROTEIN CONTROLS
K940142 · JJX
Primus Corp.
Hematology · 105d
Cleared Apr 25, 1994
CD8 CYTOSPHERES KIT
K923951 · MAM
Coulter Electronics, Inc.
Hematology · 627d
Cleared Apr 21, 1994
FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM
K924892 · DAT
Organon Teknika Corp.
Hematology · 569d
Cleared Apr 21, 1994
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
K925493 · GJA
Biomerieux Vitek, Inc.
Hematology · 535d
Cleared Apr 21, 1994
QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
K931756 · GGT
R&D Systems, Inc.
Hematology · 378d
Cleared Apr 20, 1994
HELENA THROMBOPLASTIN-MI REAGENT
K940310 · GJS
Helena Laboratories
Hematology · 86d
Cleared Apr 19, 1994
BERICHROM ANTITHROMBIN III (A)
K933125 · JPE
Behring Diagnostics, Inc.
Hematology · 295d
Cleared Apr 19, 1994
MULTIFIBREN U
K934326 · KQJ
Behring Diagnostics, Inc.
Hematology · 228d
Cleared Apr 05, 1994
PARA 5 DIFF
K935196 · JPK
Streck Laboratories, Inc.
Hematology · 161d
Cleared Apr 05, 1994
RADIAS MONOCLONAL HBA 1C ASSAY
K935613 · LCP
Bio-Rad
Hematology · 134d
Cleared Mar 31, 1994
HBM HEMOGLOBINOMETER
K933836 · GIG
Artel, Inc.
Hematology · 238d
Cleared Mar 30, 1994
ASSESS(TM) LOW ABNORMAL CONTROL
K931117 · GJS
Instrumentation Laboratory CO
Hematology · 391d
Cleared Mar 30, 1994
ASSESS(TM) HIGH ABNORMAL CONTROL
K931118 · GJS
Instrumentation Laboratory CO
Hematology · 391d
Cleared Mar 22, 1994
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
K930267 · GGC
Biomerieux Vitek, Inc.
Hematology · 427d