The following data is part of a premarket notification filed by Ramco Laboratories, Inc. with the FDA for Tfr.
| Device ID | K981208 |
| 510k Number | K981208 |
| Device Name: | TFR |
| Classification | Immunochemical, Transferrin |
| Applicant | RAMCO LABORATORIES, INC. 4507 MT.VERNON Houston, TX 77006 |
| Contact | Jeffrey B Grubb |
| Correspondent | Jeffrey B Grubb RAMCO LABORATORIES, INC. 4507 MT.VERNON Houston, TX 77006 |
| Product Code | JNM |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1998-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08600000686031 | K981208 | 000 |