510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962744Substantially Equivalent

Haemophilus Test Medium Agar (Htm)

Prepared Media Laboratory, Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962744 is the FDA 510(k) clearance record for HAEMOPHILUS TEST MEDIUM AGAR (HTM), a class II device, cleared for Prepared Media Laboratory, Inc. on under FDA product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar). FDA records list 3 510(k) clearances for Prepared Media Laboratory, Inc., from to . As of , FDA records show no recalls naming K962744.

Clearance record

Decision date
Received
(92 days to decision)
Product code
JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Regulation
21 CFR 866.1700
Device class
Class II
Review panel
Microbiology
Applicant
Prepared Media Laboratory, Inc. 15845 SW 72nd Ave., Portland OR
510(k) summary
Statement
Third party review
No

Clearances, product code JSO

Trailing 12 months

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

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