Cleared Traditional

PHOTOMETER LP 3

K801563 · Dr. Bruno Lange GmbH · Chemistry
Aug 1980
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K801563 is an FDA 510(k) clearance for the PHOTOMETER LP 3, 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 August 20, 1980, 43 days after receiving the submission on July 8, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K801563 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1980
Decision Date August 20, 1980
Days to Decision 43 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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