Cleared Traditional

CYTOMEGELISA TEST KIT (K812123) - FDA 510(k) Clearance

K812123 · M.A. Bioproducts · Microbiology device
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Sep 1981
Decision
58d
Days
-
Risk

K812123 is an FDA 510(k) clearance for the CYTOMEGELISA TEST KIT.

Submitted by M.A. Bioproducts (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Microbiology 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 M.A. Bioproducts devices

Submission Details

510(k) Number K812123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1981
Decision Date September 23, 1981
Days to Decision 58 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 102d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -