Cleared Traditional

K760112 - SPECTROPHOTOMETER (JUNIOR III) (FDA 510(k) Clearance)

Class I Toxicology device.

K760112 · The Perkin-Elmer Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1976
Decision
22d
Days
Class 1
Risk

K760112 is an FDA 510(k) clearance for the SPECTROPHOTOMETER (JUNIOR III). Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1976 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2300 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Perkin-Elmer Corp. devices

Submission Details

510(k) Number K760112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1976
Decision Date July 16, 1976
Days to Decision 22 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 87d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.