The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Alkaline Hemoglobin.
Device ID | K982426 |
510k Number | K982426 |
Device Name: | SPIFE ALKALINE HEMOGLOBIN |
Classification | System, Analysis, Electrophoretic 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 | JBD |
CFR Regulation Number | 864.7440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-13 |
Decision Date | 1998-12-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M5255527330 | K982426 | 000 |