The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia Cardiac Tdm Multi-cals.
| Device ID | K962269 |
| 510k Number | K962269 |
| Device Name: | CEDIA CARDIAC TDM MULTI-CALS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Contact | Mary Koning |
| Correspondent | Mary Koning BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-13 |
| Decision Date | 1996-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883001213 | K962269 | 000 |