The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cat. No. 1471 (110v) & Cat. No. 1472 (220v).
| Device ID | K921465 |
| 510k Number | K921465 |
| Device Name: | CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) |
| Classification | Instrument, Coagulation, Automated |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-27 |
| Decision Date | 1992-06-29 |