510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900202Substantially Equivalent

Snap Mycobacteria Avium Complex

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

K900202 is the FDA 510(k) clearance record for SNAP MYCOBACTERIA AVIUM COMPLEX, a class I device, cleared for Syngene, Inc. on under FDA product code LQF (Dna-Reagents, Mycobacterium Spp.). FDA records list 2 510(k) clearances for Syngene, Inc. As of , FDA records show no recalls naming K900202.

Clearance record

Decision date
Received
(77 days to decision)
Product code
LQF Dna-Reagents, Mycobacterium Spp.
Regulation
21 CFR 866.3370
Device class
Class I
Review panel
Microbiology
Applicant
Syngene, Inc. 10030 Barnes Canyon Rd., San Diego CA
Third party review
No

Clearances, product code LQF

Trailing 12 months

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

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