Cleared Traditional

K870988 - PRICE'S ACID-FAST STAIN (FDA 510(k) Clearance)

K870988 · Devetec, Inc. · Pathology device

Mar 1987

Decision

19d

Days

Class 1

Risk

K870988 is an FDA 510(k) clearance for the PRICE'S ACID-FAST STAIN. This device is classified as a Stains, Microbiologic (Class I - General Controls, product code JTS).

Submitted by Devetec, Inc. (Bradenton, US). The FDA issued a Cleared decision on March 30, 1987, 19 days after receiving the submission on March 11, 1987.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K870988 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 11, 1987
Decision Date	March 30, 1987
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—