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
K852751Substantially Equivalent

Tolvidine Red Unheated Serum Syphillis Card Test

Preco, Inc., Oakland NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852751 is the FDA 510(k) clearance record for TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST, a class II device, cleared for Preco, Inc. on under FDA product code GMQ (Antigens, Nontreponemal, All). FDA records list 4 510(k) clearances for Preco, Inc., from to . As of , FDA records show no recalls naming K852751.

Clearance record

Decision date
Received
(53 days to decision)
Product code
GMQ Antigens, Nontreponemal, All
Regulation
21 CFR 866.3820
Device class
Class II
Review panel
Microbiology
Applicant
Preco, Inc. 9 Post Rd., Oakland NJ
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