510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873082Substantially Equivalent

Adenoclone(tm)-Eia Adenovirus Antigen Test

Cambridge Bioscience Corp., Worcester MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873082 is the FDA 510(k) clearance record for ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST, a class I device, cleared for Cambridge Bioscience Corp. on under FDA product code GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33). FDA records list 5 510(k) clearances for Cambridge Bioscience Corp., from to . As of , FDA records show no recalls naming K873082.

Clearance record

Decision date
Received
(203 days to decision)
Product code
GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33
Regulation
21 CFR 866.3020
Device class
Class I
Review panel
Microbiology
Applicant
Cambridge Bioscience Corp. 365 Plantation St., Worcester MA
Third party review
No

Clearances, product code GOD

Trailing 12 months

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

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