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
409–432 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jun 11, 2007
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL...
K070453 · GHH
Olympus Life & Material Science...
Hematology · 115d
Cleared Jun 06, 2007
BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
K071141 · GKZ
Bd Biosciences
Hematology · 43d
Cleared Jun 06, 2007
BD TRITEST CD3/CD4/CD45, MODEL 340383
K071143 · GKZ
Bd Biosciences
Hematology · 43d
Cleared May 29, 2007
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
K062025 · OBW
Corgenix, Inc.
Hematology · 315d
Cleared May 15, 2007
STASIS - I, II AND III
K060968 · GIZ
Wortham Laboratories, Inc.
Hematology · 403d
Cleared May 11, 2007
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
K063693 · KHE
New Bay Bioresearch Co. , Ltd.
Hematology · 149d
Cleared May 11, 2007
COAGUCHEK XS PLUS SYSTEM
K071041 · GJS
Roche Diagnostics
Hematology · 29d
Cleared Mar 29, 2007
R&D SICKLE QC CONTROL
K070334 · GGM
R&D Systems, Inc.
Hematology · 52d
Cleared Mar 29, 2007
HEMOSIL PROCLOT
K070635 · GGP
Instrumentation Laboratory CO
Hematology · 22d
Cleared Mar 26, 2007
QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
K063864 · POV
Medical Electronic Systems , Ltd.
Hematology · 87d
Cleared Mar 23, 2007
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
K063356 · DAP
Dade Behring, Inc.
Hematology · 136d
Cleared Mar 16, 2007
PLASMACON N, PLASMACON L-1, PLASMACON L-2
K062306 · GGC
R2 Diagnostics, Inc.
Hematology · 220d
Cleared Mar 14, 2007
TINA-QUANT D-DIMER TEST SYSTEM
K062203 · GHH
Roche Diagnostics Corp.
Hematology · 225d
Cleared Mar 05, 2007
INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
K063673 · KHE
Innovacon, Inc.
Hematology · 84d
Cleared Mar 01, 2007
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
K062840 · GGN
Biosite Incorporated
Hematology · 160d
Cleared Feb 23, 2007
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
K061991 · GHR
Helena Laboratories
Hematology · 225d
Cleared Feb 23, 2007
RETIC-CHEX LINEARITY FOR BC
K070199 · JPK
Streck
Hematology · 32d
Cleared Feb 23, 2007
HEMOSIL ANTITHROMBIN
K070301 · JBQ
Instrumentation Laboratory CO
Hematology · 23d
Cleared Jan 31, 2007
RAPIDTEG TEG-ACT TEST
K062604 · JBP
Haemoscope Corp.
Hematology · 152d
Cleared Jan 29, 2007
TRIAGE PROTEIN C TEST
K062530 · GGP
Biosite Incorporated
Hematology · 153d
Cleared Jan 29, 2007
COAGUCHEK XS SYSTEM
K062925 · GJS
Roche Diagnostics Corp.
Hematology · 123d
Cleared Jan 29, 2007
COAGUCHEK XS PT CONTROLS
K063823 · GGN
Roche Diagnostics Corp.
Hematology · 34d
Cleared Jan 23, 2007
DUET SYSTEM
K061602 · JOY
Bioview , Ltd.
Hematology · 229d
Cleared Jan 12, 2007
ACL TOP
K063679 · GKP
Instrumentation Laboratory CO
Hematology · 32d