Cleared Traditional

K004034 - MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
(FDA 510(k) Clearance)

K004034 · Branan Medical Corp. · Toxicology device

Mar 2001

Decision

70d

Days

Class 2

Risk

K004034 is an FDA 510(k) clearance for the MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II - Special Controls, product code DKZ).

Submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on March 8, 2001, 70 days after receiving the submission on December 28, 2000.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number	K004034 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 28, 2000
Decision Date	March 08, 2001
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement