GOOClass II
Antisera, Fluorescent, All Globulins, Salmonella Spp.
21 CFR 866.3550 / Microbiology
GOO is the FDA product code for Antisera, Fluorescent, All Globulins, Salmonella Spp., a class II device type, regulated under 21 CFR 866.3550. As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- GOO
- Device name
- Antisera, Fluorescent, All Globulins, Salmonella Spp.
- Regulation
- 21 CFR 866.3550
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
