The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Modification Columnmate.
Device ID | K920820 |
510k Number | K920820 |
Device Name: | MODIFICATION COLUMNMATE |
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 | 1992-02-13 |
Decision Date | 1992-08-17 |