Cleared Traditional

K760737 - SCATTERED TRANSMISSION ACCESSORY

K760737 is an FDA 510(k) clearance for SCATTERED TRANSMISSION ACCESSORY, manufactured by The Perkin-Elmer Corp.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K760737 · The Perkin-Elmer Corp. · Chemistry device
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Nov 1976
Decision
57d
Days
Class 1
Risk

K760737 is an FDA 510(k) clearance for the SCATTERED TRANSMISSION ACCESSORY. 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 November 24, 1976 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - the FDA in vitro diagnostics and chemistry 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

FDA 510(k) Submission Details - K760737

510(k) Number K760737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1976
Decision Date November 24, 1976
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 142
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K760737.
ANALYZER, 751 KINETIC/ENDPOINT
K770306 · Sclavo, Inc. · Apr 1977
SPECTROPHOTOMETERS, INFRARED MODELS X99
K770278 · The Perkin-Elmer Corp. · Mar 1977
SPECTROPHOTOMETER, MODEL 597 IR
K770288 · The Perkin-Elmer Corp. · Mar 1977
PHOTOMETER, SEROMETER (MODEL 380)
K760395 · Mallinckrodt Critical Care · Nov 1976
PRINTER, IL 460
K760232 · Instrumentation Laboratory CO · Aug 1976
TABLE, SAMPLE IL 461
K760233 · Instrumentation Laboratory CO · Aug 1976