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
2185–2208 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Oct 17, 1986
ACTIN FSL ACTIVATED PTT REAGENT
K863594 · GGW
American Dade
Hematology · 32d
Cleared Oct 03, 1986
HEMOLYSE
K863503 · GGK
Reagent Laboratory, Inc.
Hematology · 24d
Cleared Sep 29, 1986
COAGULATOR (8 CHANNEL)
K862047 · KQG
Med USA
Hematology · 123d
Cleared Sep 29, 1986
ATAC 4300 HEMATOLOGY CELL COUNTER
K863332 · GKL
Turpen Laboratory Systems, Inc.
Hematology · 33d
Cleared Sep 16, 1986
ASSERACHROM D-DI KIT
K862156 · DAP
American Bioproducts Co.
Hematology · 103d
Cleared Sep 16, 1986
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371 · LCP
Bio-Rad
Hematology · 84d
Cleared Sep 08, 1986
TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD
K860830 · LIZ
Technicon Instruments Corp.
Hematology · 187d
Cleared Sep 04, 1986
D-DI TEST KIT
K861973 · GHH
American Bioproducts Co.
Hematology · 106d
Cleared Sep 04, 1986
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
K862374 · GKL
Instrumentation Laboratory CO
Hematology · 72d
Cleared Sep 04, 1986
ASSERACHROM PF4 KIT
K862774 · LCO
American Bioproducts Co.
Hematology · 44d
Cleared Sep 04, 1986
COULTER COUNTER MODEL T-890
K863084 · GKL
Coulter Electronics, Inc.
Hematology · 23d
Cleared Sep 04, 1986
COULTER COUNTER MODEL T-540
K863085 · GKL
Coulter Electronics, Inc.
Hematology · 23d
Cleared Sep 04, 1986
TOTAL HEMOGLOBIN
K863104 · KHG
J. D. Assoc.
Hematology · 21d
Cleared Sep 04, 1986
IL CELLECT 7
K863290 · GKL
Instrumentation Laboratory CO
Hematology · 10d
Cleared Sep 04, 1986
IL CELLECT 8
K863291 · GKL
Instrumentation Laboratory CO
Hematology · 10d
Cleared Sep 03, 1986
IL SYSTEM 810, ACL AND THE REAGENT SETS
K862301 · GJA
Instrumentation Laboratory CO
Hematology · 78d
Cleared Aug 21, 1986
U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
K862641 · KHG
U. S. Diagnostics, Inc.
Hematology · 41d
Cleared Aug 21, 1986
CBC-CAL (TM) PLUS/MULTIPLE
K862858 · KRX
R&D Systems, Inc.
Hematology · 23d
Cleared Aug 19, 1986
SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
K861697 · LCP
Awareness Technology, Inc.
Hematology · 106d
Cleared Aug 18, 1986
VISION(TM) HEMOGLOBIN
K862202 · KHG
Abbott Laboratories
Hematology · 69d
Cleared Aug 08, 1986
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K862556 · LCP
Sandare Chemical Co., Inc.
Hematology · 36d
Cleared Aug 06, 1986
COULTER COUNTER MODEL S PLUS JUNIOR
K861780 · GKL
Coulter Electronics, Inc.
Hematology · 90d
Cleared Aug 01, 1986
MULTI-CHANNEL MICROPIPETTES
K862802 · JTC
Dynatech Laboratories, Inc.
Hematology · 10d
Cleared Jul 31, 1986
BLOOD PLATELET ASSAY METHOD & APPARATUS
K862302 · JOZ
Bellhouse Medical, Inc.
Hematology · 44d