The following data is part of a premarket notification filed by Diasys Diagnostics Systems Gmbh with the FDA for Aspartate Amino Transferase (ast/sgot) Test System, Asat (got) Fs.
| Device ID | K080485 |
| 510k Number | K080485 |
| Device Name: | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | DIASYS DIAGNOSTICS SYSTEMS GMBH ALTE STRASSE 9 Holzheim, Rheinland-pfalz, DE D-65558 |
| Contact | Stephanie Klein |
| Correspondent | Stephanie Klein DIASYS DIAGNOSTICS SYSTEMS GMBH ALTE STRASSE 9 Holzheim, Rheinland-pfalz, DE D-65558 |
| Product Code | CIT |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-22 |
| Decision Date | 2008-12-04 |
| Summary: | summary |