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
361–384 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Nov 20, 2008
FACTOR VIII ANTIBODY SCREEN
K082205 · GGP
Genetic Testing Institute
Hematology · 107d
Cleared Oct 24, 2008
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
K081732 · DAP
Siemens Healthcare Diagnostics
Hematology · 127d
Cleared Oct 23, 2008
BINAXNOW G6PD TEST
K080003 · JBF
Binax, Inc.
Hematology · 295d
Cleared Oct 10, 2008
SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
K081890 · GKZ
Sysmex America, Inc.
Hematology · 100d
Cleared Oct 10, 2008
STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
K082675 · JPA
Diagnostica Stago, Inc.
Hematology · 25d
Cleared Aug 29, 2008
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
K081610 · GKZ
Sysmex America, Inc.
Hematology · 81d
Cleared Aug 14, 2008
BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
K081213 · GKZ
Bd Biosciences
Hematology · 106d
Cleared Aug 14, 2008
FLOWCARE TLG REAGENT
K081526 · GKZ
Beckman Coulter, Inc.
Hematology · 73d
Cleared Jul 31, 2008
HEMOSIL D-DIMER
K073042 · DAP
Instrumentation Laboratory
Hematology · 276d
Cleared Jul 31, 2008
CYTO-CHEX BCT
K080552 · GIM
Streck
Hematology · 154d
Cleared Jul 18, 2008
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K081719 · GKR
Stanbio Laboratory
Hematology · 30d
Cleared Jul 10, 2008
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
K081345 · JQC
Thermogenesis Corp.
Hematology · 57d
Cleared Jun 25, 2008
HEMOCCULT ICT
K080812 · KHE
Beckman Coulter, Inc.
Hematology · 93d
Cleared May 04, 2008
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
K073377 · GKP
Instrumentation Laboratory CO
Hematology · 153d
Cleared May 02, 2008
VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING...
K080911 · GKA
Bio-Rad Laboratories Inc., Clinical...
Hematology · 30d
Cleared Mar 06, 2008
DBEST ONE STEP OCCULT BLOOD TEST KITS
K071242 · KHE
Ameritek USA, Inc.
Hematology · 308d
Cleared Feb 13, 2008
DIMERTEST
K080069 · DAP
American Diagnostica, Inc.
Hematology · 34d
Cleared Feb 05, 2008
NRBC-CHEX FOR ADVIA
K080016 · GJR
Streck
Hematology · 33d
Cleared Jan 31, 2008
HANDHELD BASE UNIT
K072920 · GJS
Roche Diagnostics Corp.
Hematology · 108d
Cleared Jan 24, 2008
SPERMCHECK VASECTOMY
K073039 · POV
Princeton BioMeditech Corp.
Hematology · 87d
Cleared Jan 14, 2008
POINTCARE NOW SYSTEM
K072869 · GKZ
Pointcare Technologies, Inc.
Hematology · 97d
Cleared Jan 14, 2008
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND...
K073431 · KHE
Tianjin New Bay Bioresearch Co., Ltd.
Hematology · 39d
Cleared Dec 27, 2007
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
K073178 · JPK
R&D Systems, Inc.
Hematology · 44d
Cleared Dec 27, 2007
HEMOSIL FIBRINOGEN-C
K073367 · KQJ
Instrumentation Laboratory CO
Hematology · 27d