510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K993812Substantially Equivalent

Cvm Transport, Model R96,viral Transport, Model R99, Cvm Transport Kit, Model R96 K, Viral Transport Kit, Model R99 K

Hardy Diagnostics, Santa Maria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993812 is the FDA 510(k) clearance record for CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K, a class I device, cleared for Hardy Diagnostics on under FDA product code JSM (Culture Media, Non-Propagating Transport). FDA records list 109 510(k) clearances for Hardy Diagnostics, from to . As of , FDA records show no recalls naming K993812.

Clearance record

Decision date
Received
(41 days to decision)
Product code
JSM Culture Media, Non-Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Hardy Diagnostics 1430 W. Mccoy Ln., Santa Maria CA
510(k) summary
Statement
Third party review
No

Clearances, product code JSM

Trailing 12 months

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

FDA records show no clearances under product code JSM in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JSM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260