The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Factor Ii Deficient Substrate Plasma.
| Device ID | K834031 |
| 510k Number | K834031 |
| Device Name: | FACTOR II DEFICIENT SUBSTRATE PLASMA |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | HELENA LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-22 |
| Decision Date | 1983-12-16 |