Cleared Traditional

PERKIN-ELMER LC235 DIODE ARRAY DETECTOR (K872737) - FDA 510(k) Clearance

K872737 · The Perkin-Elmer Corp. · Toxicology device
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Sep 1987
Decision
71d
Days
-
Risk

K872737 is an FDA 510(k) clearance for the PERKIN-ELMER LC235 DIODE ARRAY DETECTOR.

Submitted by The Perkin-Elmer Corp.. The FDA issued a Cleared decision on September 18, 1987 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. 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 K872737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1987
Decision Date September 18, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 87d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -