Cleared Traditional

PSEUDO-PALETTE TM

K790992 · Micro-Palettes, Inc. · Microbiology
Jun 1979
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K790992 is an FDA 510(k) clearance for the PSEUDO-PALETTE TM, a Kit, Identification, Glucose Nonfermenter (Class I — General Controls, product code JSW), submitted by Micro-Palettes, Inc. (Mchenry, US). 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 review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K790992 FDA.gov
FDA Decision Cleared 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 JSW — Kit, Identification, Glucose Nonfermenter
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660