The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Stratus Cs Troponin I Calibrator.
| Device ID | K012233 |
| 510k Number | K012233 |
| Device Name: | STRATUS CS TROPONIN I CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Elaine H Kindell |
| Correspondent | Elaine H Kindell DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-09-11 |
| Summary: | summary |