510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K060774Substantially Equivalent

Folate on the Access Immunoassay Systems, Model A14208

Siemens Healthcare Diagnostics Inc., Chaska MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060774 is the FDA 510(k) clearance record for FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code CGN (Acid, Folic, Radioimmunoassay). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show one recall naming K060774.

Clearance record

Decision date
Received
(30 days to decision)
Product code
CGN Acid, Folic, Radioimmunoassay
Regulation
21 CFR 862.1295
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Beckman Coulter, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CGN

Trailing 12 months

FDA records hold no clearances under product code CGN in the trailing twelve months.

FDA records show no clearances under product code CGN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260