The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Actalyke Mini Activated Clotting Time Test System, Model 5750/5752.
| Device ID | K013078 |
| 510k Number | K013078 |
| Device Name: | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Patricia Franks |
| Correspondent | Patricia Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-14 |
| Decision Date | 2002-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M52557550010 | K013078 | 000 |
| M52557550000 | K013078 | 000 |
| M52557530010 | K013078 | 000 |
| M52557530000 | K013078 | 000 |