The following data is part of a premarket notification filed by Eurotrol B.v. with the FDA for Eurotrol Gas-ise Hct Qc And Eurotrol Gas-ise Hct Lvm.
| Device ID | K131595 |
| 510k Number | K131595 |
| Device Name: | EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | EUROTROL B.V. KEPLERLAAN 20 Ede, NL Nl 6716 Bs |
| Contact | Paul Kooijmans |
| Correspondent | Paul Kooijmans EUROTROL B.V. KEPLERLAAN 20 Ede, NL 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 | 2013-06-03 |
| Decision Date | 2013-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08718734961529 | K131595 | 000 |
| 08718734961512 | K131595 | 000 |
| 08718734961505 | K131595 | 000 |
| 08718734961468 | K131595 | 000 |