Cleared Traditional

K790571 - QUIK-STAIN
(FDA 510(k) Clearance)

K790571 · Dade, Baxter Travenol Diagnostics, Inc. · Hematology device

Apr 1979

Decision

31d

Days

Class 1

Risk

K790571 is an FDA 510(k) clearance for the QUIK-STAIN. This device is classified as a Wright's Stain (Class I - General Controls, product code IAF).

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1979, 31 days after receiving the submission on March 23, 1979.

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

Submission Details

510(k) Number	K790571 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 23, 1979
Decision Date	April 23, 1979
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—