The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia Core Tdm Multi-cal.
| Device ID | K961659 |
| 510k Number | K961659 |
| Device Name: | CEDIA CORE TDM MULTI-CAL |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM CO. 1059 KINGSMILL PARKWAY Columbus, OH |
| Contact | Mary Koning |
| Correspondent | Mary Koning BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM CO. 1059 KINGSMILL PARKWAY Columbus, OH |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-30 |
| Decision Date | 1996-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883001268 | K961659 | 000 |