Product code GOK— Microbiology

FDA has cleared 11 devices under product code GOK between 1977 and 1983, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19831 clearance
• 19811 clearance
• 19802 clearances
• 19791 clearance
• 19784 clearances
• 19772 clearances

• Organon, Inc.2 clearances
• Microbiological Assoc.2 clearances
• Flow Laboratories, Inc.2 clearances
• Ortho Diagnostics, Inc.1 clearance
• Northeast Biomedical Labs., Inc.1 clearance
• Electro-Nucleonics Laboratories, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• Abbott Laboratories1 clearance

• K832228 — RUBASCAN LATEX CARD TESTBd Becton Dickinson Vacutainer Systems Preanalytic·1983-09-29
• K810835 — RUBAZYME - MAbbott Laboratories·1981-05-05
• K792635 — ANTIBODY TO RUBELLA VIRUSElectro-Nucleonics Laboratories, Inc.·1980-03-19
• K792133 — RUBELISA TEST KITMicrobiological Assoc.·1980-01-11
• K790122 — RUBANONOrganon, Inc.·1979-02-15
• K781638 — RUBINDEX*DIRECT SYSTEMOrtho Diagnostics, Inc.·1978-12-20
• K781392 — CYTOMEGILISH TEST KITMicrobiological Assoc.·1978-10-24
• K780010 — GOAT ANTI-RUBELLA ANTISERANortheast Biomedical Labs., Inc.·1978-01-20
• K780063 — RUBENOSTICONOrganon, Inc.·1978-01-20
• K771956 — HUMAN O BUFFERFlow Laboratories, Inc.·1977-10-28
• K771957 — RUBELLA HEMAGGLUTINATION REAGENT KITFlow Laboratories, Inc.·1977-10-28