The following data is part of a premarket notification filed by Ramco Laboratories, Inc. with the FDA for Spectro Vwf.
| Device ID | K861159 |
| 510k Number | K861159 |
| Device Name: | SPECTRO VWF |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | RAMCO LABORATORIES, INC. 4507 MT.VERNON Houston, TX 77006 |
| Contact | Clarence P Alfrey |
| Correspondent | Clarence P Alfrey 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 | 1986-03-28 |
| Decision Date | 1986-05-01 |