The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Analytes Albumin, Total Bilirubin, Ast, Alt Gen2 S.
| Device ID | K851308 |
| 510k Number | K851308 |
| Device Name: | ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard A Dwarcia |
| Correspondent | Leonard A Dwarcia TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-04-17 |