Cleared Traditional

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

K812123 · M.A. Bioproducts · Microbiology device
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, 58 days after receiving the submission on July 27, 1981.

This device falls under the Microbiology FDA review panel.

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 —

Device Classification

Product Code —
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