510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921573Substantially Equivalent

Rubella Igm

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

K921573 is the FDA 510(k) clearance record for RUBELLA IGM, a class II device, cleared for Clark Laboratories, Inc. on under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). FDA records list 25 510(k) clearances for Trinity Biotech USA, from to . As of , FDA records show no recalls naming K921573.

Clearance record

Decision date
Received
(147 days to decision)
Product code
LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Clark Laboratories, Inc. 53 Cedar Lake Rd., Blairstown NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LFX

Trailing 12 months
1 clearance under product code LFX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260