Cleared Traditional

MICRO LOWRY PROTEINTEST

K792347 · Panmed, Inc. · Chemistry
Dec 1979
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K792347 is an FDA 510(k) clearance for the MICRO LOWRY PROTEINTEST, a Lowry (colorimetric), Total Protein (Class II — Special Controls, product code JGP), submitted by Panmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979, 17 days after receiving the submission on November 19, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K792347 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1979
Decision Date December 06, 1979
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JGP — Lowry (colorimetric), Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635