Cleared Traditional

K780242 - SPECTROPHOTOMETER

K780242 is an FDA 510(k) clearance for SPECTROPHOTOMETER, manufactured by The Perkin-Elmer Corp.. The device is a Class 1 Chemistry device with product code KHO cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K780242 · The Perkin-Elmer Corp. · Chemistry device
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Mar 1978
Decision
42d
Days
Class 1
Risk

K780242 is an FDA 510(k) clearance for the SPECTROPHOTOMETER, FLUORESCENCE M.650-10. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1978 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - 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 - K780242

510(k) Number K780242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1978
Decision Date March 27, 1978
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

KHO Device Classification - Class 1, General Controls

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
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 - KHO Fluorometer, For Clinical Use

All 29
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K780242.
FLUOROMATIC ANALYZER AND AUTOSAMPLER
K791329 · Bio-Rad · Jul 1979
SPECTROPHOTOMETER MODEL 3000
K790235 · The Perkin-Elmer Corp. · Mar 1979
SPECTROPHOTOMETER MODEL 650-40
K790236 · The Perkin-Elmer Corp. · Mar 1979
SPECTROFLUOROMETER SF-330
K780362 · Varian Assoc., Inc. · Mar 1978
HTSH RIA
K780122 · Abbott Laboratories · Feb 1978
DETECTOR, MODEL LC-100 FLUORESCENCE
K760261 · The Perkin-Elmer Corp. · Sep 1976