Helena Laboratories · Class II · Cleared Jan 18, 1991
| K-number | K904247 |
| Device name | FREE PROTEIN S REAGENT CAT. NO. 5363 |
| Applicant | Helena Laboratories |
| Product code | GGP |
| Device class | Class II |
| Decision date | Jan 18, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 864.7290 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov