Product code GRP— Microbiology

FDA has cleared 6 devices under product code GRP between 1982 and 1989, filed by 6 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.

• 19891 clearance
• 19851 clearance
• 19831 clearance
• 19823 clearances

• Seragen Diagnostics, Inc.1 clearance
• Hyland Therapeutic Div., Travenol Laboratories1 clearance
• Diagnostica, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• Armkel, LLC1 clearance
• American Micro Scan1 clearance

• K884967 — BACTIGEN(R) H. INFLUENZAE TYPE BArmkel, LLC·1989-02-07
• K854490 — IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TESAmerican Micro Scan·1985-12-27
• K831525 — H-FLU B ELISA TESTSeragen Diagnostics, Inc.·1983-09-29
• K823348 — H. INFLUENZA B ANTISERA FOR CIEDiagnostica, Inc.·1982-12-28
• K821266 — BBL DIRECTIGEN MENINGITIS TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic·1982-06-01
• K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUMHyland Therapeutic Div., Travenol Laboratories·1982-03-11