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
1993–2016 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 12, 1988
KVM ISOTONIC FLUSH SOLUTION
K883989 · GIF
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM ISOTONIC DILUENT
K883990 · GIF
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM HEMOGLOBIN LYSING REAGENT
K883991 · GGK
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM PREPACK HEMATOLOGY REAGENT SET
K883992 · GKK
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 06, 1988
HEMOGLOBIN
K883683 · GJZ
Tech-Co, Inc.
Hematology · 38d
Cleared Sep 30, 1988
COLORECTAL CANCER RISK DETECTOR (TM)
K874180 · KHE
Pearce Clinical Laboratories, Inc.
Hematology · 352d
Cleared Sep 30, 1988
REP GLYCO SYSTEM
K881863 · LCP
Helena Laboratories
Hematology · 150d
Cleared Sep 30, 1988
HELENA COLOCARE
K882799 · KHE
Helena Laboratories
Hematology · 86d
Cleared Sep 14, 1988
COULTER CLONE B1 MONOCLONAL ANTIBODY
K882557 · GKZ
Coulter Immunology
Hematology · 85d
Cleared Sep 13, 1988
VISION(R) PROTHROMBIN TIME
K883441 · GJS
Abbott Laboratories
Hematology · 29d
Cleared Sep 07, 1988
HEMATRAK(R) MODEL 590
K882579 · GKZ
Priority Service Systems
Hematology · 76d
Cleared Sep 07, 1988
SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER
K882612 · GKZ
Baker Instructions Corp.
Hematology · 75d
Cleared Sep 02, 1988
STACHROM ANTIPLASMIN TEST KIT
K882602 · GGP
American Bioproducts Co.
Hematology · 70d
Cleared Sep 02, 1988
STACHROM ANTIPLASMIN CONTROL
K882603 · GGP
American Bioproducts Co.
Hematology · 70d
Cleared Aug 30, 1988
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
K882480 · GGN
International Technidyne Corp.
Hematology · 75d
Cleared Aug 30, 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
K882481 · GGN
International Technidyne Corp.
Hematology · 75d
Cleared Aug 25, 1988
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K882325 · GFO
Sclavo, Inc.
Hematology · 80d
Cleared Aug 25, 1988
SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER
K882370 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 78d
Cleared Aug 25, 1988
COAG-I ANALYZER, ALPHA MODEL
K882444 · JPA
Cardiovascular Diagnostic Services
Hematology · 72d
Cleared Aug 25, 1988
COAG-I PT TEST CARD
K882456 · GJS
Cardiovascular Diagnostic Services
Hematology · 72d
Cleared Aug 25, 1988
OWREN'S VERONAL BUFFER
K883484 · JPA
Helena Laboratories
Hematology · 9d
Cleared Aug 18, 1988
SAFECRIT PLASTIC MICROHEMATOCRIT TUBES
K883185 · GHY
Norfolk Scientific, Inc.
Hematology · 21d
Cleared Aug 17, 1988
PLATELIN(R) EXCEL L
K881999 · GIT
Organon Teknika Corp.
Hematology · 97d
Cleared Aug 17, 1988
DIMERTEST(R) LATEX
K882944 · DAP
Agen Biomedical , Ltd.
Hematology · 34d