Cleared Traditional

AUTOSCAN 3 (K792647) - FDA 510(k) Clearance

Class I Microbiology device.

K792647 · Cnr Labs · Microbiology device
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Mar 1980
Decision
82d
Days
Class 1
Risk

K792647 is an FDA 510(k) clearance for the AUTOSCAN 3. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Cnr Labs (Mchenry, US). The FDA issued a Cleared decision on March 17, 1980 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2300 - the FDA microbiology 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 Cnr Labs devices

Submission Details

510(k) Number K792647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1979
Decision Date March 17, 1980
Days to Decision 82 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 102d · This submission: 82d
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.

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

All 32
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K792647.
DRUG DETECTION SYSTEM
K802619 · Syva Co. · Oct 1980
AGA UV PHOTOMETER
K801499 · Syva Co. · Aug 1980
BECKMAN MODEL 42 SPECTROPHOTOMETER
K801373 · Beckman Instruments, Inc. · Jul 1980
HEMESPEC
K782035 · Helena Laboratories · Jan 1979
UROTRON
K781632 · Boehringer Mannheim Corp. · Dec 1978
DUAL WAVELENGTH PHOTOMETER, 1177
K771909 · Abbott Laboratories · Dec 1977