Cleared Traditional

K770638 - DETECTOR

K770638 is the FDA 510(k) clearance for DETECTOR by Peokin-Elmer Corp.. It is a Class 1 Toxicology device (product code KIE) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K770638 · Peokin-Elmer Corp. · Toxicology device
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Jun 1977
Decision
81d
Days
Class 1
Risk

K770638 is an FDA 510(k) clearance for the DETECTOR, UV, MOLEL GC-55. Classified as Apparatus, High Pressure Liquid Chromatography (product code KIE), Class I - General Controls.

Submitted by Peokin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2260 - 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 Peokin-Elmer Corp. devices

Submission Details

510(k) Number K770638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1977
Decision Date June 24, 1977
Days to Decision 81 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 87d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIE Apparatus, High Pressure Liquid Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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 - KIE Apparatus, High Pressure Liquid Chromatography

All 14
Devices cleared under the same product code (KIE) and FDA review panel - the closest regulatory comparables to K770638.
MODEL 5000, LIQUID CHROMATOGRAPHY
K781379 · Varian Assoc., Inc. · Sep 1978
AUTO. SAMPLING SYSTEM
K772364 · Hewlett-Packard Co. · Jan 1978
MONITOR, LIQ. CHROMATOGRAPHY LC-15 UV
K771156 · The Perkin-Elmer Corp. · Aug 1977
L080 SERIES LIQUID CHROMATOGRAPH
K761351 · Hewlett-Packard Co. · Feb 1977
SERIES II LIQUID CHROMATOGRAPH
K761219 · The Perkin-Elmer Corp. · Feb 1977