510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943621Substantially Equivalent

Rapid Yeast Plus System

Innovative Diagnostic Systems, Inc., Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943621 is the FDA 510(k) clearance record for RAPID YEAST PLUS SYSTEM, a class I device, cleared for Innovative Diagnostic Systems, Inc. on under FDA product code JXB (Kit, Identification, Yeast). FDA records list 11 510(k) clearances for Innovative Diagnostic Systems, Inc., from to . As of , FDA records show 2 recalls naming K943621.

Clearance record

Decision date
Received
(184 days to decision)
Product code
JXB Kit, Identification, Yeast
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Innovative Diagnostic Systems, Inc. 3404 Oakcliff Rd. #C-1, Atlanta GA
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