RAPID YEAST PLUS SYSTEM— 510(k) K943621

Name: FDA 510(k) clearance K943621
Creator: U.S. Food and Drug Administration
Published: 1995-01-27

Substantially Equivalent

Innovative Diagnostic Systems, Inc.

FDA 510(k) clearance K943621 for RAPID YEAST PLUS SYSTEM, Substantially Equivalent on 1995-01-27. Applicant: Innovative Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Innovative Diagnostic Systems, Inc.
Product code: Code JXB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1994-07-27
Decision date: 1995-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K943621

K-number listed on FDA's recall record

Z-0530-2014 — remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.Class II·Terminated·Remel Inc·20130404

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K943621.

Data sourced from openFDA. This site is unofficial and independent of the FDA.