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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

270 results for "Beckman Coulter, Inc."
265–270 of 270
Search insights Median review: 71d Cleared: 100% Top manufacturer: Beckman Coulter, Inc. Lead specialty: Chemistry
Cleared Jul 06, 1998
VIGIL HEMOGLOBIN (HBALC) CONTROLS
K982022 · JJX
Beckman Coulter, Inc.
Hematology · 27d
Cleared Jun 12, 1998
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
K981864 · JJX
Beckman Coulter, Inc.
Chemistry · 16d
Cleared Jun 12, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K981638 · DCK
Beckman Coulter, Inc.
Immunology · 35d
Cleared Jan 29, 1996
ACCESS FOLATE ASSAY (MODIFICATION)
K955434 · CGN
Beckman Coulter, Inc.
Chemistry · 119d
Cleared Aug 26, 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
K943149 · CGN
Beckman Coulter, Inc.
Immunology · 57d
Cleared Oct 12, 1993
ACCESS FOLATE ASSAY
K932887 · CGN
Beckman Coulter, Inc.
Immunology · 120d