FLUORESCENT ANTIBODY CONJUGATE FOR GP.A

Antisera, Fluorescent, All Groups, Streptococcus Spp.

SPRINGWOOD MICROBIOLOGICALS

The following data is part of a premarket notification filed by Springwood Microbiologicals with the FDA for Fluorescent Antibody Conjugate For Gp.a.

Pre-market Notification Details

• Device ID: K812013
• 510k Number: K812013
• Device Name: FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
• Classification: Antisera, Fluorescent, All Groups, Streptococcus Spp.
• Applicant: SPRINGWOOD MICROBIOLOGICALS 803 N. Front St. Suite 3 McHenry, IL 60050
• Product Code: GTX
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-07-17
• Decision Date: 1981-07-28