The following data is part of a premarket notification filed by Universal Reagents, Inc. with the FDA for Factor Deficient Plasmas - Factor Ix (9).
Device ID | K972288 |
510k Number | K972288 |
Device Name: | FACTOR DEFICIENT PLASMAS - FACTOR IX (9) |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | UNIVERSAL REAGENTS, INC. 2858 N. PENNSYLVANIA ST. Indianapolis, IN 46205 |
Contact | Jorge Miller |
Correspondent | Jorge Miller UNIVERSAL REAGENTS, INC. 2858 N. PENNSYLVANIA ST. Indianapolis, IN 46205 |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-19 |
Decision Date | 1997-07-14 |