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
793–816 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jan 22, 2001
INSTACCULT
K002930 · KHE
Medtek Diagnostics, LLC
Hematology · 124d
Cleared Jan 16, 2001
CD-CAL PLUS CALIBRATOR
K003991 · KRX
R&D Systems, Inc.
Hematology · 21d
Cleared Jan 12, 2001
!NSURE FECAL OCCULT BLOOD TEST
K002457 · KHE
Enterix, Inc.
Hematology · 155d
Cleared Jan 12, 2001
CBC-4K HEMATOLOGY CONTROL
K003874 · JPK
R&D Systems, Inc.
Hematology · 28d
Cleared Dec 26, 2000
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
K003677 · GKZ
Abx Diagnostics
Hematology · 27d
Cleared Dec 19, 2000
VARIANT II TOTAL GHB
K003280 · LCP
Bio-Rad
Hematology · 61d
Cleared Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120 · LCP
Roche Diagnostics Corp.
Hematology · 74d
Cleared Dec 01, 2000
PENTRA 5D
K003534 · JPK
R&D Systems, Inc.
Hematology · 15d
Cleared Nov 29, 2000
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · GGM
Bio-Rad
Hematology · 62d
Cleared Nov 27, 2000
COLOSCREEN-ES
K003359 · KHE
Helena Laboratories
Hematology · 31d
Cleared Nov 16, 2000
BEHRING COAGULATION SYSTEM, MODEL BCS
K002080 · JPA
Dade Behring, Inc.
Hematology · 129d
Cleared Nov 07, 2000
R & D 3K RETIC
K003208 · JPK
R&D Systems, Inc.
Hematology · 25d
Cleared Oct 26, 2000
ABX MICROS CRP
K002646 · GKZ
Abx Diagnostics
Hematology · 63d
Cleared Oct 13, 2000
COALIZA PROTEIN S-FREE
K002467 · GGP
Instrumentation Laboratory CO
Hematology · 63d
Cleared Oct 05, 2000
REFACTO LABORATORY STANDARD
K002350 · GGP
The Genetics Institute
Hematology · 64d
Cleared Sep 26, 2000
DRX HBA1C - FOR PRESCRIPTION HOME USE
K000885 · LCP
Metrika, Inc.
Hematology · 190d
Cleared Sep 26, 2000
PROTEIN C REAGENT
K002541 · GGP
Dade Behring, Inc.
Hematology · 41d
Cleared Sep 14, 2000
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
K002177 · JPA
Haemoscope Corp.
Hematology · 57d
Cleared Sep 11, 2000
FETALTROL
K002511 · JPK
Trillium Diagnostics, LLC
Hematology · 27d
Cleared Sep 06, 2000
COAGUCHEK S SYSTEM, MODEL 2138280
K994349 · JPA
Roche Diagnostics Corp.
Hematology · 258d
Cleared Aug 31, 2000
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE...
K002528 · JBP
Sienco, Inc.
Hematology · 15d
Cleared Aug 30, 2000
SLIDESCAN
K001420 · JOY
Applied Imaging Corp.
Hematology · 117d
Cleared Aug 30, 2000
MODIFICATION OF ACL ADVANCE
K002400 · JPA
Instrumentation Laboratory CO
Hematology · 26d
Cleared Aug 21, 2000
GLYCOSAL HBA1C TEST
K001392 · LCP
Provalis Diagnostics , Ltd.
Hematology · 110d