Cleared Traditional

K771585 - T3 UPTAKE DIAG. KIT
(FDA 510(k) Clearance)

K771585 · Antibodies, Inc. · Chemistry device
Sep 1977
Decision
26d
Days
—
Risk

K771585 is an FDA 510(k) clearance for the T3 UPTAKE DIAG. KIT..

Submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1977, 26 days after receiving the submission on August 18, 1977.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number K771585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1977
Decision Date September 13, 1977
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code —
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