Product code GSB— Microbiology

FDA has cleared 5 devices under product code GSB between 1980 and 1985, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19851 clearance
• 19842 clearances
• 19831 clearance
• 19801 clearance

• Orion Diagnostica, Inc.1 clearance
• Miles Laboratories, Inc.1 clearance
• Microbix Biosystems, Inc.1 clearance
• Institute Virion , Ltd.1 clearance
• Hillcrest Biologicals1 clearance

• K852933 — MYCOPLASMA SPP SEROLOGICAL REAGENTSMicrobix Biosystems, Inc.·1985-08-01
• K843664 — MYCOPLASMA PNEUMONIAEInstitute Virion , Ltd.·1984-10-25
• K834338 — MYCOPLASMA PNEUMONIAE CF ANTIGENHillcrest Biologicals·1984-02-27
• K832132 — SERA-TEK MYCOPLASMA ANTIBODY TESTMiles Laboratories, Inc.·1983-09-20
• K802934 — MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROLOrion Diagnostica, Inc.·1980-12-31