Cleared Traditional

URINARY/CSF PROTEIN

K913615 · Boehringer Mannheim Corp. · Chemistry
Sep 1991
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K913615 is an FDA 510(k) clearance for the URINARY/CSF PROTEIN, a Turbidimetric, Total Protein (Class II — Special Controls, product code JGQ), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on September 13, 1991, 31 days after receiving the submission on August 13, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K913615 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1991
Decision Date September 13, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGQ — Turbidimetric, Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635

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