Cleared Traditional

K821175 - GASTRIN RADIOIMMUNOASSAY KIT (125-I)
(FDA 510(k) Clearance)

K821175 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device

May 1982

Decision

18d

Days

Class 1

Risk

K821175 is an FDA 510(k) clearance for the GASTRIN RADIOIMMUNOASSAY KIT (125-I). This device is classified as a Radioimmunoassay, Gastrin (Class I - General Controls, product code CGC).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 14, 1982, 18 days after receiving the submission on April 26, 1982.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1325.

Submission Details

510(k) Number	K821175 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 26, 1982
Decision Date	May 14, 1982
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—