Helena Laboratories · Class II · Cleared Mar 15, 1990
| K-number | K896174 |
| Device name | PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359 |
| Applicant | Helena Laboratories |
| Product code | GGP |
| Device class | Class II |
| Decision date | Mar 15, 1990 |
| 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