The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Trace Albumin-mr Reagent.
Device ID | K923322 |
510k Number | K923322 |
Device Name: | TRACE ALBUMIN-MR REAGENT |
Classification | Bromcresol Green Dye-binding, Albumin |
Applicant | TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
Contact | Peter Murphy |
Correspondent | Peter Murphy TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
Product Code | CIX |
CFR Regulation Number | 862.1035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-07 |
Decision Date | 1992-09-11 |