Cleared Traditional

K790772 - CHEMTAB
(FDA 510(k) Clearance)

K790772 · Boehringer Mannheim Corp. · Chemistry
Jun 1979
Decision
56d
Days
Class 2
Risk

K790772 is an FDA 510(k) clearance for the CHEMTAB, a Method, Metallic Reduction, Glucose (urinary, Non-quantitative) (Class II — Special Controls, product code JIM), submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979, 56 days after receiving the submission on April 20, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1340.

Submission Details

510(k) Number K790772 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 1979
Decision Date June 15, 1979
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIM — Method, Metallic Reduction, Glucose (urinary, Non-quantitative)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1340