FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Pathology ×
1,105 results
985–1008 of 1,105
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Feb 04, 1982
MODIFIED EA 50
K820027 · HZJ
Surgipath
Pathology · 30d
Cleared Jan 26, 1982
HEPAQUANT
K813011 · JOX
Streck Laboratories, Inc.
Pathology · 91d
Cleared Dec 31, 1981
AFRICAN GREEN MONKEY BLOOD IN ALSERVERS
K813513 · LHW
Dutchland Laboratories, Inc.
Pathology · 16d
Cleared Dec 29, 1981
TISSUE PROCESSING CASSETTES & ACCESS
K813430 · IDL
American Optical Corp.
Pathology · 21d
Cleared Dec 29, 1981
SAC-CEL
K813508 · KTS
Burroughs Wellcome Co.
Pathology · 14d
Cleared Dec 29, 1981
RHESUS MONKEY BLOOD IN ALSEVER'S
K813512 · LHW
Dutchland Laboratories, Inc.
Pathology · 14d
Cleared Dec 22, 1981
INORGANIC PHOSPHORUS REAGENT SET
K813400 · CEO
Anco Medical Reagents & Assoc.
Pathology · 18d
Cleared Dec 10, 1981
10% NEUTRAL BUFFERED FORMALIN CONCENT
K812940 · IFP
Surgipath
Pathology · 51d
Cleared Nov 10, 1981
NEUTRAL DUFFERED FORMA-SCENT
K812817 · IFP
Meridian Diagnostics, Inc.
Pathology · 34d
Cleared Nov 10, 1981
CHANG MEDIUM
K812820 · KIT
Hana Biologics, Inc.
Pathology · 34d
Cleared Oct 23, 1981
ACCRA LAB HEMOTOLOGY
K812848 · IAF
Accra Laboratories, Inc.
Pathology · 14d
Cleared Sep 23, 1981
IMMULIK STAIN PLATE
K812497 · IEG
Immulok, Inc.
Pathology · 23d
Cleared Sep 23, 1981
ACCRA LAB WRIGHT STAIN
K812504 · IAF
Accra Laboratories, Inc.
Pathology · 22d
Cleared Sep 23, 1981
RABBIT COMPLEMENT
K812522 · KTQ
Dutchland Laboratories, Inc.
Pathology · 21d
Cleared Sep 08, 1981
GUINEA PIG SERUM - STERILE
K812379 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
RABBIT SERUM - STERILE
K812380 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
DONOR HORSE SERUM - STERILE
K812381 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
DONOR CALF (BOVINE-SERUM) - STERILE
K812382 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
CALF (BOVINE) SERUM - STERILE
K812383 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
NEWBORN CALF SERUM - STERILE
K812384 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
NATAL CALF (BOVINE) SERUM - STERILE
K812385 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
FETAL BOVINE SERUM - STERILE
K812386 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Aug 13, 1981
EA 65
K812086 · HZJ
Surgipath
Pathology · 22d
Cleared Aug 13, 1981
EA 50
K812087 · HZJ
Surgipath
Pathology · 22d