510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993633Substantially Equivalent

Synthetic Vdrl Antigen

Centers for Disease Control and Prevention, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993633 is the FDA 510(k) clearance record for SYNTHETIC VDRL ANTIGEN, a class II device, cleared for Centers for Disease Control and Prevention on under FDA product code GMQ (Antigens, Nontreponemal, All). FDA records list 30 510(k) clearances for Centers for Disease Control and Prevention, from to . As of , FDA records show no recalls naming K993633.

Clearance record

Decision date
Received
(119 days to decision)
Product code
GMQ Antigens, Nontreponemal, All
Regulation
21 CFR 866.3820
Device class
Class II
Review panel
Microbiology
Applicant
Centers for Disease Control and Prevention 1600 Clifton Rd., NE, Atlanta GA
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