510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800908Substantially Equivalent

Capik-Candida Albicans Ident. Kit.

IMMY, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800908 is the FDA 510(k) clearance record for CAPIK-CANDIDA ALBICANS IDENT. KIT., a class I device, cleared for Immuno-Mycologics, Inc. on under FDA product code JXB (Kit, Identification, Yeast). FDA records list 26 510(k) clearances for IMMY, Inc., from to . As of , FDA records show no recalls naming K800908.

Clearance record

Decision date
Received
(42 days to decision)
Product code
JXB Kit, Identification, Yeast
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Immuno-Mycologics, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JXB

Trailing 12 months

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

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