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
1801–1824 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Apr 11, 1990
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
K901233 · GGC
Ortho Diagnostic Systems, Inc.
Hematology · 28d
Cleared Apr 02, 1990
SIMULTEST IMK PLUS(TM)
K900078 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 88d
Cleared Mar 30, 1990
COULTER JT3
K896873 · GKZ
Coulter Corp.
Hematology · 112d
Cleared Mar 27, 1990
HEPARIN CONTROL PLASMA, FOR USE IN APTT
K900782 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Mar 27, 1990
RISTOCETIN
K900792 · GHR
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Mar 23, 1990
TIP TOP(R) DISPENSER CAPS
K896670 · GJW
Helena Laboratories
Hematology · 116d
Cleared Mar 15, 1990
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
K896174 · GGP
Helena Laboratories
Hematology · 141d
Cleared Mar 15, 1990
ORTHOKROME* FACTOR VIII
K900395 · GGP
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* HEPARIN
K900396 · KFF
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* ANTIPLASMIN
K900397 · GGP
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* PROTEIN C
K900398 · GGP
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* PLASMINOGEN
K900399 · GGP
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 15, 1990
ORTHOKROME* ANTITHROMBIN
K900400 · JBQ
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Mar 14, 1990
TECHNICON H*2(TM) SYSTEM
K900593 · GKZ
Technicon Instruments Corp.
Hematology · 35d
Cleared Mar 12, 1990
MODIFIED COATRON II AND COATRON JR.
K900506 · JPA
Astral Medical Systems
Hematology · 38d
Cleared Mar 09, 1990
RET-CHECK
K900484 · GJR
Streck Laboratories, Inc.
Hematology · 36d
Cleared Mar 06, 1990
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
K900377 · JPA
Baxter Healthcare Corp
Hematology · 39d
Cleared Mar 06, 1990
FACTOR V DEFICIENT PLASMA
K900406 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR VII DEFICIENT PLASMA
K900407 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR VIII DEFICIENT PLASMA
K900408 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR IX DEFICIENT PLASMA
K900409 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR X DEFICIENT PLASMA
K900410 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR XI DEFICIENT PLASMA
K900411 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
FACTOR XII DEFICIENT PLASMA
K900412 · GJT
Sigma Chemical Co.
Hematology · 36d