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
337–360 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared May 28, 2009
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · JBQ
Siemens Healthcare Diagnostics
Hematology · 339d
Cleared May 08, 2009
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED),...
K083729 · GGW
Aniara Diagnostica, LLC
Hematology · 143d
Cleared May 06, 2009
PATHFAST D-DIMER
K072288 · GHH
Mitsubishi Kagaku Iatron
Hematology · 629d
Cleared Apr 21, 2009
CHEMPAQ XBC ANALYZER
K090013 · GKZ
Chempaq A/S
Hematology · 109d
Cleared Apr 15, 2009
TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
K082091 · GKZ
Reametrix, Inc.
Hematology · 265d
Cleared Mar 27, 2009
UA-CELLULAR FOR IQ
K090201 · JPK
Streck
Hematology · 59d
Cleared Mar 26, 2009
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
K082227 · GKA
Sebia
Hematology · 231d
Cleared Mar 26, 2009
THE BELMONT BUDDY LITE FLUID WARMER
K090508 · BSB
Belmont Instrument Corp.
Hematology · 28d
Cleared Mar 18, 2009
STAK-CHEX PLUS RETICS
K090137 · GLQ
Streck
Hematology · 56d
Cleared Mar 13, 2009
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
K083518 · JPA
Instrumentation Laboratory CO
Hematology · 107d
Cleared Feb 11, 2009
CD4 COUNT
K083926 · GGL
Streck
Hematology · 42d
Cleared Feb 04, 2009
CELL-DYN EMERALD SYSTEM
K081495 · GKZ
Abbott Laboratories
Hematology · 251d
Cleared Feb 03, 2009
COULTER BODY FLUID CONTROL
K082162 · JPK
Beckman Coulter, Inc.
Hematology · 187d
Cleared Feb 03, 2009
X-CAL
K083200 · KRX
Streck
Hematology · 96d
Cleared Feb 03, 2009
MEDONIC M SERIES
K083420 · GKZ
Boule Medical AB
Hematology · 76d
Cleared Jan 26, 2009
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND...
K083159 · JPA
Siemens Healthcare Diagnostics
Hematology · 91d
Cleared Jan 26, 2009
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND...
K083175 · JPA
Siemens Healthcare Diagnostics
Hematology · 90d
Cleared Jan 21, 2009
COULTER 6C CELL CONTROL, MODELS 628027 & A59925
K081822 · JPK
Beckman Coulter, Inc.
Hematology · 208d
Cleared Jan 16, 2009
COULTER LIN-X LINEARITY CONTROL
K081641 · JPK
Beckman Coulter, Inc.
Hematology · 219d
Cleared Dec 19, 2008
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
K081930 · GKZ
Beckman Coulter, Inc.
Hematology · 165d
Cleared Dec 19, 2008
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
K082859 · GGN
Instrumentation Laboratory CO
Hematology · 81d
Cleared Dec 17, 2008
THROMBO TEK PSE, MODEL 90-480
K082631 · GGP
R2 Diagnostics, Inc.
Hematology · 98d
Cleared Dec 12, 2008
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
K082248 · JPA
Diagnostica Stago, Inc.
Hematology · 126d
Cleared Dec 05, 2008
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
K080595 · JOY
CellaVision AB
Hematology · 277d