The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Actalyke Qc Kit, Models Aqc-hp And Aqc-lp.
| Device ID | K061014 |
| 510k Number | K061014 |
| Device Name: | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 -0752 |
| Contact | Patricia Franks |
| Correspondent | Patricia Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 -0752 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-05-10 |
| Summary: | summary |