The following data is part of a premarket notification filed by Eurotrol B.v. with the FDA for Eurotrol Gas-ise Metabolites.
| Device ID | K121468 |
| 510k Number | K121468 |
| Device Name: | EUROTROL GAS-ISE METABOLITES |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | EUROTROL B.V. KEPLERLAAN 20 Ede, NL 6716 Bs |
| Contact | Paul B.p. Kooijmans |
| Correspondent | Paul B.p. Kooijmans EUROTROL B.V. KEPLERLAAN 20 Ede, NL 6716 Bs |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-17 |
| Decision Date | 2012-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08718734960928 | K121468 | 000 |
| 08718734960904 | K121468 | 000 |
| 08718734960881 | K121468 | 000 |
| 08718734960867 | K121468 | 000 |