Cleared Traditional

MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO (K800720) - FDA 510(k) Clearance

K800720 · Macomb Chemical Co. · Chemistry device
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Apr 1980
Decision
21d
Days
-
Risk

K800720 is an FDA 510(k) clearance for the MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO.

Submitted by Macomb Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1980 after a review of 21 days - a notably fast clearance cycle.

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: 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 Macomb Chemical Co. devices

Submission Details

510(k) Number K800720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1980
Decision Date April 21, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -