Photometer LP 300

FDA 510(k) K832531 · Dr. Bruno Lange GmbH

Substantially Equivalent

510(k) numberK832531

Submission

Device name
Photometer LP 300
Applicant
Dr. Bruno Lange GmbH
Mchenry, IL, US
Received
July 29, 1983
Decision date
December 12, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2300
Specialty
Clinical Chemistry

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More from Bio-Tek Instruments, Inc.

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K834226Flame PhotometersJJO · Traditional 06/22/1984SE
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Questions and answers

When was Photometer LP 300 cleared by the FDA?

Photometer LP 300 (K832531) received a 510(k) decision of Substantially Equivalent on December 12, 1983, 136 days after the submission was received.

What is the product code of K832531?

The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.