Cleared Traditional

PLATELET KIT

K772105 · Streck Laboratories, Inc. · Hematology

Nov 1977

Decision

23d

Days

Class 1

Risk

About This 510(k) Submission

K772105 is an FDA 510(k) clearance for the PLATELET KIT, a Platelet Counting, Manual (Class I — General Controls, product code GLG), submitted by Streck Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1977, 23 days after receiving the submission on November 7, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6160.

Submission Details

510(k) Number	K772105 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 1977
Decision Date	November 30, 1977
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—