510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000687Substantially Equivalent

The Daya Syphilis Test/the Trust Antigen Test

Beacon Biologicals, Inc., Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000687 is the FDA 510(k) clearance record for THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST, a class II device, cleared for Beacon Biologicals, Inc. on under FDA product code GMQ (Antigens, Nontreponemal, All). FDA records list one 510(k) clearance for Beacon Biologicals, Inc. As of , FDA records show no recalls naming K000687.

Clearance record

Decision date
Received
(104 days to decision)
Product code
GMQ Antigens, Nontreponemal, All
Regulation
21 CFR 866.3820
Device class
Class II
Review panel
Microbiology
Applicant
Beacon Biologicals, Inc. 6004 Glendale Dr., Boca Raton FL
510(k) summary
Statement
Third party review
No

Clearances, product code GMQ

Trailing 12 months

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

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