510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993554Substantially Equivalent

Yeastest

Diagnostic Markers, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993554 is the FDA 510(k) clearance record for YEASTEST, a class I device, cleared for Diagnostic Markers, Inc. on under FDA product code JXB (Kit, Identification, Yeast). FDA records list one 510(k) clearance for Diagnostic Markers, Inc. As of , FDA records show no recalls naming K993554.

Clearance record

Decision date
Received
(113 days to decision)
Product code
JXB Kit, Identification, Yeast
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Diagnostic Markers, Inc. 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
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