The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Glucose Hk Gen.3, Ise Indirect Na For Gen.2, Elecsys Tsh, Cobas Pro Integrated Solutions.
| Device ID | K191899 |
| 510k Number | K191899 |
| Device Name: | Glucose HK Gen.3, ISE Indirect Na For Gen.2, Elecsys TSH, Cobas Pro Integrated Solutions |
| Classification | Hexokinase, Glucose |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Khoa Tran |
| Correspondent | Khoa Tran Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | CFR |
| 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 | 2019-07-16 |
| Decision Date | 2019-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121283 | K191899 | 000 |