The following data is part of a premarket notification filed by Ramco Laboratories, Inc. with the FDA for Vfe.
| Device ID | K983107 |
| 510k Number | K983107 |
| Device Name: | VFE |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-04 |
| Decision Date | 1998-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08600000686048 | K983107 | 000 |