The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Columnmate Ii.
| Device ID | K921676 |
| 510k Number | K921676 |
| Device Name: | COLUMNMATE II |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1992-07-10 |