510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953066Substantially Equivalent

Serodia Atg

Fujirebio America, Inc., West Cadwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953066 is the FDA 510(k) clearance record for SERODIA ATG, a class II device, cleared for Fujirebio America, Inc. on under FDA product code DDC (Thyroglobulin, Antigen, Antiserum, Control). FDA records list 2 510(k) clearances for Fujirebio America, Inc., from to . As of , FDA records show no recalls naming K953066.

Clearance record

Decision date
Received
(45 days to decision)
Product code
DDC Thyroglobulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Fujirebio America, Inc. 1129 Bloomfield Ave., West Cadwell NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DDC

Trailing 12 months

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

FDA records show no clearances under product code DDC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DDC, 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