Cleared Traditional

PROTEINMETER

K863112 · J. D. Assoc. · Chemistry
Dec 1986
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K863112 is an FDA 510(k) clearance for the PROTEINMETER, a Lowry (colorimetric), Total Protein (Class II — Special Controls, product code JGP), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 10, 1986, 119 days after receiving the submission on August 13, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K863112 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1986
Decision Date December 10, 1986
Days to Decision 119 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