The following data is part of a premarket notification filed by Ramco Laboratories, Inc. with the FDA for Vwf Immunoblot.
Device ID | K864701 |
510k Number | K864701 |
Device Name: | VWF IMMUNOBLOT |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | RAMCO LABORATORIES, INC. 4507 MT.VERNON Houston, TX 77006 |
Contact | Tami Alfrey |
Correspondent | Tami 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 | 1986-12-02 |
Decision Date | 1987-03-30 |