Cleared Traditional

SPQ PAL CONTROL LEVEL II

K934966 · Incstar Corp. · Immunology

Jan 1994

Decision

88d

Days

Class 1

Risk

About This 510(k) Submission

K934966 is an FDA 510(k) clearance for the SPQ PAL CONTROL LEVEL II, a Prealbumin, Fitc, Antigen, Antiserum, Control (Class I — General Controls, product code DDS), submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on January 11, 1994, 88 days after receiving the submission on October 15, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5060.

Submission Details

510(k) Number	K934966 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 1993
Decision Date	January 11, 1994
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF