510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K943049Substantially Equivalent

Mycoakt M. Avium Culture Id Kit

Dynagen, Inc., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943049 is the FDA 510(k) clearance record for MYCOAKT M. AVIUM CULTURE ID KIT, a class I device, cleared for Dynagen, Inc. on under FDA product code JSY (Kit, Identification, Mycobacteria). FDA records list 6 510(k) clearances for Dynagen, Inc., from to . As of , FDA records show no recalls naming K943049.

Clearance record

Decision date
Received
(259 days to decision)
Product code
JSY Kit, Identification, Mycobacteria
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Dynagen, Inc. 99 Erie St.,, Cambridge MA
510(k) summary
Statement
Third party review
No

Clearances, product code JSY

Trailing 12 months

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

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