Cleared Traditional

K972963 - MODIFIED CEDIA DAU PCP ASSAY (FDA 510(k) Clearance)

K972963 · Boehringer Mannheim Corp. · Toxicology device

Sep 1997

Decision

42d

Days

—

Risk

K972963 is an FDA 510(k) clearance for the MODIFIED CEDIA DAU PCP ASSAY. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on September 22, 1997, 42 days after receiving the submission on August 11, 1997.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K972963 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 11, 1997
Decision Date	September 22, 1997
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF