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
241–264 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Mar 14, 2013
STA- COAG CONTROL (N+ABN) PLUS
K120014 · GGN
Diagnostica Stago, Inc.
Hematology · 441d
Cleared Feb 12, 2013
STA COMPACT MAX
K130090 · JPA
Diagnostica Stago, Incorporated
Hematology · 29d
Cleared Jan 24, 2013
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
K112120 · GHH
Diazyme Laboratories
Hematology · 549d
Cleared Jan 07, 2013
AVIE TOTAL HB TEST SYSTEM
K121752 · GKR
Mec Dynamics Corp
Hematology · 207d
Cleared Dec 28, 2012
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB...
K121397 · KHE
SEKISUI Diagnostics, LLC
Hematology · 233d
Cleared Dec 19, 2012
IND ONE STEP OCCULT BLOOD (FOB) TEST
K113506 · KHE
Ind Diagnostics, Inc.
Hematology · 387d
Cleared Oct 22, 2012
XN CAL PF
K120747 · KRX
Streck
Hematology · 224d
Cleared Oct 19, 2012
SYSMEX XN-SERIES
K112605 · GKZ
Sysmex America, Inc.
Hematology · 408d
Cleared Oct 19, 2012
XN CHECK
K120742 · JPK
Streck
Hematology · 221d
Cleared Oct 19, 2012
XN CHECK BF
K120744 · JPK
Streck
Hematology · 221d
Cleared Oct 19, 2012
XN CAL
K120745 · KRX
Streck
Hematology · 221d
Cleared Aug 02, 2012
ABACUS 3CP
K111534 · GKZ
Diatron U.S., Inc.
Hematology · 427d
Cleared Jul 31, 2012
VIDAS D-DIMER EXCLUSION II (DEX2)
K112818 · DAP
bioMerieux, Inc.
Hematology · 307d
Cleared Jul 27, 2012
MULTIPLATE 5.0 AGGREGOMETER
K103555 · JOZ
Verum Diagnostica GmbH
Hematology · 602d
Cleared May 25, 2012
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
K112550 · GKA
Sebia
Hematology · 267d
Cleared May 24, 2012
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
K112491 · GKA
Sebia
Hematology · 269d
Cleared CT May 01, 2012
INRATIO2 PI/NR MONITORING SYSTEM
K110212 · GJS
Alere San Diego, Inc (Formally...
Hematology · 462d
Cleared Mar 27, 2012
ABACUS 5
K112755 · GKZ
Diatron U.S., Inc.
Hematology · 188d
Cleared Jan 04, 2012
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
K113211 · GGN
Instrumentation Laboratory CO
Hematology · 65d
Cleared Dec 22, 2011
CELL-DYN EMERALD 22 SYSTEM
K110381 · GKZ
Abbott Laboratories
Hematology · 315d
Cleared Dec 22, 2011
CELL-DYN 22 PLUS CALIBRATOR
K111204 · KRX
Streck
Hematology · 237d
Cleared Dec 22, 2011
CELL-DYN 22 PLUS CONTROL
K111211 · GLQ
Streck
Hematology · 237d
Cleared Dec 19, 2011
NOFACT VIII
K102851 · GJT
R2 Diagnostics, Inc.
Hematology · 446d
Cleared Dec 19, 2011
NOFACT IX
K102908 · GJT
R2 Diagnostics, Inc.
Hematology · 444d