510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964015Substantially Equivalent

Indicard Test

Litmus Concepts, Inc., Front Royal VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964015 is the FDA 510(k) clearance record for INDICARD TEST, a class I device, cleared for Litmus Concepts, Inc. on under FDA product code MJM (Dna Probe, Gardnerella Vaginalis). FDA records list 2 510(k) clearances for Litmus Concepts, Inc., from to . As of , FDA records show no recalls naming K964015.

Clearance record

Decision date
Received
(255 days to decision)
Product code
MJM Dna Probe, Gardnerella Vaginalis
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Litmus Concepts, Inc. P.O. Box 296, Front Royal VA
510(k) summary
Statement
Third party review
No

Clearances, product code MJM

Trailing 12 months

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

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