GROUP A STREP POSITIVE AND NEGATIVE CONTROLS

Antisera, All Groups, Streptococcus Spp.

QUIDEL CORP.

The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Group A Strep Positive And Negative Controls.

Pre-market Notification Details

• Device ID: K912868
• 510k Number: K912868
• Device Name: GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
• Classification: Antisera, All Groups, Streptococcus Spp.
• Applicant: QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121
• Contact: Craig E Watson
• Correspondent: Craig E Watson; QUIDEL CORP. 10165 MCKELLAR COURT San Diego, CA 92121
• Product Code: GTZ
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-06-28
• Decision Date: 1991-08-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30014613003540	K912868	000