Cleared Traditional

ULTRACHEM CREA #64972 (K821472) - FDA 510(k) Clearance

K821472 · Emd Chemicals, Inc. · Chemistry device
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Jun 1982
Decision
16d
Days
-
Risk

K821472 is an FDA 510(k) clearance for the ULTRACHEM CREA #64972.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982 after a review of 16 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K821472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 03, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -