The following data is part of a premarket notification filed by Rochdiag with the FDA for Calibrator For Automated Systems (c.f.a.s.) Lipids.
| Device ID | K011658 |
| 510k Number | K011658 |
| Device Name: | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ROCHDIAG 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Helen T Torney |
| Correspondent | Helen T Torney ROCHDIAG 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-29 |
| Decision Date | 2001-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630936403 | K011658 | 000 |
| 04015630920983 | K011658 | 000 |