Product code GNY— Microbiology

FDA has cleared 4 devices under product code GNY between 1977 and 1993, filed by 3 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.

• 19931 clearance
• 19891 clearance
• 19772 clearances

• Flow Laboratories, Inc.2 clearances
• Whittaker Bioproducts, Inc.1 clearance
• Light Diagnostics1 clearance

• K922801 — RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAYLight Diagnostics·1993-01-06
• K885310 — MURINE MONOCLONAL ANTI-ADENOVIRUS IGGWhittaker Bioproducts, Inc.·1989-02-16
• K770807 — ADENOVIRUS-GROUP FA LABELLED (8-651 RF)Flow Laboratories, Inc.·1977-05-20
• K770811 — ADENOVIRUS GROUP-FA LABELLED PRESERUMFlow Laboratories, Inc.·1977-05-20