The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cascade 480(tm) Auto Coag Analyzer, Modification.
| Device ID | K914946 |
| 510k Number | K914946 |
| Device Name: | CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION |
| 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 | 1991-10-29 |
| Decision Date | 1992-01-13 |