Cleared Traditional

K953534 - AXSYM PHENCYCLIDINE II (FDA 510(k) Clearance)

K953534 · Abbott Laboratories · Toxicology device

Oct 1995

Decision

91d

Days

—

Risk

K953534 is an FDA 510(k) clearance for the AXSYM PHENCYCLIDINE II. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 26, 1995, 91 days after receiving the submission on July 27, 1995.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K953534 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 27, 1995
Decision Date	October 26, 1995
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF