510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980638Substantially Equivalent

Adi Syphilis Rpr Liquid Controls

Ampcor Diagnostics, Inc., Bridgeport NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980638 is the FDA 510(k) clearance record for ADI SYPHILIS RPR LIQUID CONTROLS, a class II device, cleared for Ampcor Diagnostics, Inc. on under FDA product code GMP (Antisera, Control For Nontreponemal Tests). FDA records list one 510(k) clearance for Ampcor Diagnostics, Inc. As of , FDA records show no recalls naming K980638.

Clearance record

Decision date
Received
(137 days to decision)
Product code
GMP Antisera, Control For Nontreponemal Tests
Regulation
21 CFR 866.3820
Device class
Class II
Review panel
Microbiology
Applicant
Ampcor Diagnostics, Inc. 603 Heron Dr., Bldg. 3, Bridgeport NJ
510(k) summary
Statement
Third party review
No

Clearances, product code GMP

Trailing 12 months

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

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