Cleared Traditional

K842579 - B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS
(FDA 510(k) Clearance)

Jul 1984
Decision
24d
Days
Class 1
Risk

K842579 is an FDA 510(k) clearance for the B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS. This device is classified as a Kit, Quality Control For Culture Media (Class I - General Controls, product code JTR).

Submitted by Biological & Environmental Control Laboratories (Walker, US). The FDA issued a Cleared decision on July 27, 1984, 24 days after receiving the submission on July 3, 1984.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2480.

Submission Details

510(k) Number K842579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date July 27, 1984
Days to Decision 24 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JTR — Kit, Quality Control For Culture Media
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2480

Similar Devices — JTR Kit, Quality Control For Culture Media

All 11
PROTECT T.M.
K871121 · Pro-Lab, Inc. · Apr 1987
FEKAL CHECK PARASITOLOGY CONTROL SLIDE
K862914 · Trend Scientific, Inc. · Sep 1986
KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS
K861022 · Micro-Bio-Logics · Apr 1986
INDI KWIK (TM) CO/TWO KIT
K855198 · Micro-Bio-Logics · Jan 1986
LYFO-DISK MICROORGANISMS
K842129 · Micro-Bio-Logics · Jul 1984
LYOPHILIZED MICROORGANISMS
K831653 · Austin Biological Laboratories · Jul 1983