Cleared Traditional

PHOTOMETER LP 300

K832531 · Dr. Bruno Lange GmbH · Chemistry
Dec 1983
Decision
136d
Days
Class 1
Risk

About This 510(k) Submission

K832531 is an FDA 510(k) clearance for the PHOTOMETER LP 300, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Dr. Bruno Lange GmbH (Mchenry, US). The FDA issued a Cleared decision on December 12, 1983, 136 days after receiving the submission on July 29, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K832531 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1983
Decision Date December 12, 1983
Days to Decision 136 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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