The following data is part of a premarket notification filed by Universal Reagents, Inc. with the FDA for Universal Reagent Factor Xii (twelve) Deficient Plasma.
| Device ID | K973143 |
| 510k Number | K973143 |
| Device Name: | UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA |
| 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 | 1997-08-22 |
| Decision Date | 1997-09-25 |
| Summary: | summary |