DeviceClearance

Product code GOM— Microbiology

ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Classification name
Antisera, Cf, Rubella
Device class
Class 2
Regulation
21 CFR 866.3510
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code GOM

FDA has cleared 2 devices under product code GOM, all in 1995, filed by 1 applicant company. 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.

Top applicants under product code GOM

Recent clearances under product code GOM

Data sourced from openFDA. This site is unofficial and independent of the FDA.