510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K861080Substantially Equivalent

Cellematics Viral/chlamydal Transport Pack(modifi)

Difco Laboratories, Inc., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861080 is the FDA 510(k) clearance record for CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI), a class I device, cleared for Difco Laboratories, Inc. on under FDA product code JSM (Culture Media, Non-Propagating Transport). FDA records list 121 510(k) clearances for Difco Laboratories, Inc., from to . As of , FDA records show no recalls naming K861080.

Clearance record

Decision date
Received
(17 days to decision)
Product code
JSM Culture Media, Non-Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Difco Laboratories, Inc. 1180 Ellsworth Rd., Ann Arbor MI
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