The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas Pure Integrated Solutions, Glucose Hk Gen.3, Ise Indirect Na For Gen.2, Online Dat Methadone Ii, Elecsys Tsh.
| Device ID | K220134 |
| 510k Number | K220134 |
| Device Name: | Cobas Pure Integrated Solutions, Glucose HK Gen.3, ISE Indirect Na For Gen.2, ONLINE DAT Methadone II, Elecsys TSH |
| Classification | Hexokinase, Glucose |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Noel Mencias |
| Correspondent | Noel Mencias Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | CFR |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JLW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-18 |
| Decision Date | 2022-09-16 |