510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971502Substantially Equivalent

Serodia Tp-Pa

Scimedx Tekfile Services, Denvill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971502 is the FDA 510(k) clearance record for SERODIA TP-PA, a class II device, cleared for Scimedx Tekfile Services on under FDA product code GMT (Antigens, Ha, Treponema Pallidum). FDA records list one 510(k) clearance for Scimedx Tekfile Services. As of , FDA records show no recalls naming K971502.

Clearance record

Decision date
Received
(203 days to decision)
Product code
GMT Antigens, Ha, Treponema Pallidum
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Scimedx Tekfile Services 400 Ford Rd., Denvill NJ
510(k) summary
Statement
Third party review
No

Clearances, product code GMT

Trailing 12 months

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

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