510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904613Substantially Equivalent

Trichinella Serology Microtiter Elisa

Lmd Laboratories, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904613 is the FDA 510(k) clearance record for TRICHINELLA SEROLOGY MICROTITER ELISA, a class I device, cleared for Lmd Laboratories on under FDA product code GPG (Antigen, Latex Agglutination, Trichinella Spiralis). FDA records list 12 510(k) clearances for Lmd Laboratories, from to . As of , FDA records show no recalls naming K904613.

Clearance record

Decision date
Received
(161 days to decision)
Product code
GPG Antigen, Latex Agglutination, Trichinella Spiralis
Regulation
21 CFR 866.3850
Device class
Class I
Review panel
Microbiology
Applicant
Lmd Laboratories 4626 Santa Fe St., San Diego CA
Third party review
No

Clearances, product code GPG

Trailing 12 months

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

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