Product code GWC— Microbiology

FDA has cleared 9 devices under product code GWC between 1980 and 1989, filed by 7 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.

• 19892 clearances
• 19871 clearance
• 19861 clearance
• 19842 clearances
• 19831 clearance
• 19821 clearance
• 19801 clearance

• Armkel, LLC3 clearances
• Wellcome Diagnostics1 clearance
• Ventrex Laboratories, Inc.1 clearance
• Pharmacia, Inc.1 clearance
• Lkb Instruments, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• American Micro Scan1 clearance

• K884965 — BACTIGEN(R) MENINGITIDIS PANELArmkel, LLC·1989-02-07
• K884966 — BACTIGEN(R) S. PNEUMONIAEArmkel, LLC·1989-02-07
• K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAEAmerican Micro Scan·1987-03-25
• K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110Lkb Instruments, Inc.·1986-12-18
• K842239 — VENTRESCREEN STREP A TESTVentrex Laboratories, Inc.·1984-07-02
• K841376 — WELLCOGEN S. PNEUMONIAEWellcome Diagnostics·1984-05-02
• K831887 — BACTIGEN S. PNEUMONIAEArmkel, LLC·1983-09-26
• K821960 — BBL PNEUMOSLIDE TESTBd Becton Dickinson Vacutainer Systems Preanalytic·1982-07-30
• K802337 — PHADEBACT PNEUMOCOCCUS TESTPharmacia, Inc.·1980-10-31