Cleared Traditional

K780680 - UNIT, SPECTRA, CORRECTED, DIFFERENTIAL (FDA 510(k) Clearance)

K780680 · The Perkin-Elmer Corp. · Chemistry device
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Aug 1978
Decision
106d
Days
-
Risk

K780680 is an FDA 510(k) clearance for the UNIT, SPECTRA, CORRECTED, DIFFERENTIAL.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1978 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Chemistry 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all The Perkin-Elmer Corp. devices

Submission Details

510(k) Number K780680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1978
Decision Date August 08, 1978
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -