The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Ife-6.
| Device ID | K973040 |
| 510k Number | K973040 |
| Device Name: | SPIFE IFE-6 |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| 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 | CFF |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-14 |
| Decision Date | 1998-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M5255527030 | K973040 | 000 |
| M5255526970 | K973040 | 000 |
| M5255526950 | K973040 | 000 |
| M5255526940 | K973040 | 000 |
| M5255527440 | K973040 | 000 |
| M5255527370 | K973040 | 000 |