Cleared Traditional

K873594 - TIF FECAL TEST
(FDA 510(k) Clearance)

K873594 · Devetec, Inc. · Pathology device

Sep 1987

Decision

25d

Days

Class 1

Risk

K873594 is an FDA 510(k) clearance for the TIF FECAL TEST. This device is classified as a Preservative, Cytological (Class I - General Controls, product code LEA).

Submitted by Devetec, Inc. (Bradenton, US). The FDA issued a Cleared decision on September 29, 1987, 25 days after receiving the submission on September 4, 1987.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K873594 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 04, 1987
Decision Date	September 29, 1987
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—