Cleared Traditional

K920559 - ABBOTT VERTEX ANALYZER
(FDA 510(k) Clearance)

K920559 · Abbott Laboratories · Chemistry device

Mar 1992

Decision

41d

Days

Class 1

Risk

K920559 is an FDA 510(k) clearance for the ABBOTT VERTEX ANALYZER. This device is classified as a Counter (beta, Gamma) For Clinical Use (Class I - General Controls, product code JJJ).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 19, 1992, 41 days after receiving the submission on February 7, 1992.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2320.

Submission Details

510(k) Number	K920559 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 07, 1992
Decision Date	March 19, 1992
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF