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
2161–2184 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Feb 06, 1987
ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
K864534 · JPA
Medical Laboratory Automation...
Hematology · 81d
Cleared Feb 06, 1987
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
K864664 · KSA
Technicon Instruments Corp.
Hematology · 70d
Cleared Feb 04, 1987
IMMUNO-SURE
K864611
Coulter Electronics, Inc.
Hematology · 72d
Cleared Jan 21, 1987
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
K864480 · GGP
Instrumentation Laboratory CO
Hematology · 69d
Cleared Jan 05, 1987
IL TEST 97575-15, HEPARIN ASSAY
K864211 · KFF
Instrumentation Laboratory CO
Hematology · 69d
Cleared Jan 05, 1987
PROTIME AUTOMATE TEST KIT
K864392 · GJS
American Bioproducts Co.
Hematology · 60d
Cleared Jan 05, 1987
COAGULATION INTRINSIC DEFICIENT PLASMAS
K864481 · GGP
Instrumentation Laboratory CO
Hematology · 53d
Cleared Jan 05, 1987
COAGULATION EXTRINSIC DEFICIENT PLASMAS
K864497 · GGP
Instrumentation Laboratory CO
Hematology · 52d
Cleared Jan 05, 1987
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646 · GKF
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 41d
Cleared Dec 09, 1986
HEMOCCULT WIPE TEST
K862849 · KHE
Smithkline Diagnostics, Inc.
Hematology · 133d
Cleared Dec 04, 1986
IL TEST 97573-15, PLASMINOGEN ASSAY
K864212 · DDX
Instrumentation Laboratory CO
Hematology · 37d
Cleared Dec 04, 1986
SIMPLASTIN EXCEL
K864283 · GJS
Organon Teknika Corp.
Hematology · 35d
Cleared Nov 25, 1986
IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
K864213 · LGP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Nov 25, 1986
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214 · JBQ
Instrumentation Laboratory CO
Hematology · 28d
Cleared Nov 25, 1986
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
K864271 · JPA
Instrumentation Laboratory CO
Hematology · 27d
Cleared Nov 13, 1986
ERYTHOCYTE CREATINE
K852767 · JLA
Panmed, Inc.
Hematology · 503d
Cleared Nov 13, 1986
THROMBOPLASTIN.FS
K864272 · GJS
American Dade
Hematology · 15d
Cleared Nov 13, 1986
THROMBOPLASTIN.C
K864273 · GJS
American Dade
Hematology · 15d
Cleared Nov 13, 1986
THROMBOPLASTIN.R
K864274 · GJS
American Dade
Hematology · 15d
Cleared Nov 06, 1986
NATURAL DETECTOR SYSTEM
K861731 · KHE
U.S. Health Resources Corp.
Hematology · 184d
Cleared Nov 06, 1986
PIASTRINIT
K863114 · GGK
J. D. Assoc.
Hematology · 85d
Cleared Oct 29, 1986
HEMATALL-C PLUS HEMATOLOGY CONTROLS
K863224 · JPK
Fisher Scientific Co., LLC
Hematology · 69d
Cleared Oct 29, 1986
MICROHEMATOCRIT CENTRIFUGE
K864039 · GKF
Plaza Medical, Inc.
Hematology · 13d
Cleared Oct 22, 1986
ASSERACHROM B-TG KIT
K862775 · JBX
American Bioproducts Co.
Hematology · 92d