The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Porphobilinogen (pbg).
| Device ID | K961984 |
| 510k Number | K961984 |
| Device Name: | PORPHOBILINOGEN (PBG) |
| Classification | Ion-exchange Resin, Ehrlich's Reagent, Porphobilinogen |
| Applicant | TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Product Code | JNF |
| CFR Regulation Number | 862.1590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-21 |
| Decision Date | 1996-12-10 |