510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K010050Substantially Equivalent

Advia Centaur and Acs: 180 Folate Immunoassay

Bayer Diagnostics Corp., Medfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010050 is the FDA 510(k) clearance record for ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY, a class II device, cleared for Bayer Diagnostics Corp. on under FDA product code CGN (Acid, Folic, Radioimmunoassay). FDA records list 32 510(k) clearances for Bayer Diagnostics Corp., from to . As of , FDA records show 14 recalls naming K010050.

Clearance record

Decision date
Received
(31 days to decision)
Product code
CGN Acid, Folic, Radioimmunoassay
Regulation
21 CFR 862.1295
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bayer Diagnostics Corp. 63 N. St., Medfield MA
510(k) summary
Summary
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