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
2017–2040 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Aug 12, 1988
BINAX EQUATE GLYCOHEMOGLOBIN
K874749 · LCP
Binax, Inc.
Hematology · 268d
Cleared Aug 09, 1988
FIBRINOGENTEST-O
K881685 · GIS
Diatech, Inc.
Hematology · 112d
Cleared Aug 01, 1988
BIO-RAD HEMOGLOBIN DETECTOR
K882051 · LCP
Bio-Rad
Hematology · 77d
Cleared Aug 01, 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · LCP
Bio-Rad
Hematology · 67d
Cleared Jul 25, 1988
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
K882490 · GIF
R&D Systems, Inc.
Hematology · 39d
Cleared Jul 18, 1988
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
K882501 · GIM
Terumo Medical Corp.
Hematology · 31d
Cleared Jul 18, 1988
HEMOCUE HEMOGLOBIN CALIBRATOR
K882600 · KRZ
React and Co.
Hematology · 24d
Cleared Jul 18, 1988
SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
K882767 · GKH
Toa Medical Electronics USA, Inc.
Hematology · 12d
Cleared Jul 12, 1988
SYSMEX QUICKLYSER-II (QLS-200A)
K882267 · GIF
Toa Medical Electronics USA, Inc.
Hematology · 42d
Cleared Jul 08, 1988
IMMUNOCCULT EIA TEST KIT
K871143 · KHE
Intl. Immunoassay Laboratories, Inc.
Hematology · 473d
Cleared Jul 08, 1988
HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
K881907 · KHE
Enzo Biochem, Inc.
Hematology · 63d
Cleared Jul 01, 1988
SPECTROLYSE/FIBRIN
K881037 · GGP
Cytrx Biopool, Ltd.
Hematology · 112d
Cleared Jul 01, 1988
PAT PLATELET AGGREGATION TEST
K881829 · JBX
Streck Laboratories, Inc.
Hematology · 63d
Cleared Jul 01, 1988
HEMOGLOBIN SCREENING DEVICE
K882101 · KSL
Portable Medical Laboratories, Inc.
Hematology · 51d
Cleared Jul 01, 1988
MINIFUGE, MODEL 70
K882149 · GPG
Utah Bioresearch, Inc.
Hematology · 39d
Cleared Jul 01, 1988
SIMPLASTIN EXCEL S
K882214 · GJS
Organon Teknika Corp.
Hematology · 36d
Cleared Jun 29, 1988
ASTROSCAN 2100 MICROTITER PLATE READER
K881458 · JJQ
Astroscan , Ltd.
Hematology · 83d
Cleared Jun 27, 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
K881367 · JPA
Instrumentation Laboratory CO
Hematology · 88d
Cleared May 23, 1988
HEMOCCULT SENSITIVE TEST
K880499 · KHE
Smithkline Diagnostics, Inc.
Hematology · 108d
Cleared May 18, 1988
COAG-A-MATE(R) XM
K881281 · GKP
Organon Teknika Corp.
Hematology · 54d
Cleared May 13, 1988
REVISED IMMUDIA HEM-SP
K874482 · KHE
Schiff & Co.
Hematology · 206d
Cleared May 13, 1988
MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
K881186 · GHY
Helps Products, Inc.
Hematology · 53d
Cleared May 06, 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
K880698 · LCP
Helena Laboratories
Hematology · 74d
Cleared May 06, 1988
CLP NORMAL COAGULATION CONTROL
K880712 · GIZ
Creative Laboratory Products, Inc.
Hematology · 74d