Cleared Traditional

K790991 - YEAST-PALETTE TM
(FDA 510(k) Clearance)

Jun 1979
Decision
24d
Days
Class 1
Risk

K790991 is an FDA 510(k) clearance for the YEAST-PALETTE TM. This device is classified as a Kit, Identification, Yeast (Class I - General Controls, product code JXB).

Submitted by Micro-Palettes, Inc.. The FDA issued a Cleared decision on June 22, 1979, 24 days after receiving the submission on May 29, 1979.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K790991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1979
Decision Date June 22, 1979
Days to Decision 24 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JXB — Kit, Identification, Yeast
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2660