510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863164Substantially Equivalent

Agar Reduction in Formula for Pdc 110 & 310 Media

Precision Dynamics Corporation, San Fernando CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863164 is the FDA 510(k) clearance record for AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA, a class I device, cleared for Precision Dynamics Corp. on under FDA product code JSM (Culture Media, Non-Propagating Transport). FDA records list 26 510(k) clearances for Precision Dynamics Corp., from to . As of , FDA records show no recalls naming K863164.

Clearance record

Decision date
Received
(9 days to decision)
Product code
JSM Culture Media, Non-Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Precision Dynamics Corp. 13880 Del Sur St., San Fernando CA
Third party review
No

Clearances, product code JSM

Trailing 12 months
1 clearance under product code JSM in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JSM, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260