Cleared Traditional

K842588 - SIMULTROPIN RADIOIMMUNOASSAY KIT LH (FDA 510(k) Clearance)

K842588 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device

Aug 1984

Decision

38d

Days

—

Risk

K842588 is an FDA 510(k) clearance for the SIMULTROPIN RADIOIMMUNOASSAY KIT LH..

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 10, 1984, 38 days after receiving the submission on July 3, 1984.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number	K842588 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 03, 1984
Decision Date	August 10, 1984
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	—
Device Class	—