Cleared Traditional

K873408 - MODEL 690 SPECTROPHOTOMETER
(FDA 510(k) Clearance)

Sep 1987
Decision
14d
Days
Class 1
Risk

K873408 is an FDA 510(k) clearance for the MODEL 690 SPECTROPHOTOMETER. This device is classified as a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I - General Controls, product code JJQ).

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on September 8, 1987, 14 days after receiving the submission on August 25, 1987.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K873408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1987
Decision Date September 08, 1987
Days to Decision 14 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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