The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Hemoram/aggram Analyzer.
| Device ID | K050053 |
| 510k Number | K050053 |
| Device Name: | HEMORAM/AGGRAM ANALYZER |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-10 |
| Decision Date | 2005-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M5258JF520010 | K050053 | 000 |
| M52514870000 | K050053 | 000 |
| M52514840020 | K050053 | 000 |
| M52514840010 | K050053 | 000 |
| M52514840000 | K050053 | 000 |