The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimensions Rxl Myoglobin (myo) Calibrator.
| Device ID | K984193 |
| 510k Number | K984193 |
| Device Name: | DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash 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 | 1998-11-23 |
| Decision Date | 1998-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768013720 | K984193 | 000 |