The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Norm-trol.
| Device ID | K792310 |
| 510k Number | K792310 |
| Device Name: | NORM-TROL |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | HELENA LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-16 |
| Decision Date | 1979-12-04 |