The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Columnmate(tm) Beta-thal Cat. No. 4515.
Device ID | K913384 |
510k Number | K913384 |
Device Name: | COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 |
Classification | Hemoglobin A2 Quantitation |
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 | JPD |
CFR Regulation Number | 864.7400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-29 |
Decision Date | 1991-12-17 |