Product code GPW— Microbiology

FDA has cleared 4 devices under product code GPW between 1981 and 1987, filed by 4 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.

• 19871 clearance
• 19852 clearances
• 19811 clearance

• Sita, Inc.1 clearance
• Institute Virion , Ltd.1 clearance
• Hillcrest Biologicals1 clearance
• Electro-Nucleonics Laboratories, Inc.1 clearance

• K872700 — YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGENSita, Inc.·1987-10-15
• K843654 — CHLAMYDIAInstitute Virion , Ltd.·1985-08-08
• K844868 — CHLAMYDIA GROUP CF ANTIGENHillcrest Biologicals·1985-03-05
• K811570 — ANTIBODY TO CHLAMYDIA TRACHOMATISElectro-Nucleonics Laboratories, Inc.·1981-07-23