510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980596Substantially Equivalent

Vca Igm Elisa Test System

Trinity Biotech USA, Frederick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980596 is the FDA 510(k) clearance record for VCA IGM ELISA TEST SYSTEM, a class I device, cleared for Clark Laboratories, Inc. on under FDA product code LSE (Epstein-Barr Virus, Other). FDA records list 25 510(k) clearances for Trinity Biotech USA, from to . As of , FDA records show no recalls naming K980596.

Clearance record

Decision date
Received
(155 days to decision)
Product code
LSE Epstein-Barr Virus, Other
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Clark Laboratories, Inc. 1306f Bailes Ln., Frederick MD
510(k) summary
Summary
Third party review
No

Clearances, product code LSE

Trailing 12 months

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

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