510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864239Substantially Equivalent

Cled Agar with Andrades Indicator

Mds Laboratories, Inc., L5j 2m4, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864239 is the FDA 510(k) clearance record for CLED AGAR WITH ANDRADES INDICATOR, a class I device, cleared for Mds Laboratories, Inc. on under FDA product code JSH (Culture Media, Non-Selective And Differential). FDA records list 21 510(k) clearances for Mds Laboratories, Inc., from to . As of , FDA records show no recalls naming K864239.

Clearance record

Decision date
Received
(154 days to decision)
Product code
JSH Culture Media, Non-Selective And Differential
Regulation
21 CFR 866.2320
Device class
Class I
Review panel
Microbiology
Applicant
Mds Laboratories, Inc. 2200 S. Sheridan Way, L5j 2m4, CA
Third party review
No

Clearances, product code JSH

Trailing 12 months

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

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