Cleared Traditional

THREE SPIKE CUP

K922870 · Osteo Technology, Inc. · Microbiology

Apr 1993

Decision

308d

Days

Class 1

Risk

About This 510(k) Submission

K922870 is an FDA 510(k) clearance for the THREE SPIKE CUP, a Antiserum, Cf, Rubeola (Class I — General Controls, product code GRF), submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on April 8, 1993, 308 days after receiving the submission on June 4, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3520.

Submission Details

510(k) Number	K922870 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 1992
Decision Date	April 08, 1993
Days to Decision	308 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement