The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Iron Calibrator.
| Device ID | K060266 |
| 510k Number | K060266 |
| Device Name: | DIMENSION IRON CALIBRATOR |
| Classification | Calibrator, Primary |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY Newark,, DE 19714 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker DADE BEHRING, INC. P.O. BOX 6101 BUILDING 500 GLASGOW BUSINESS COMMUNITY Newark,, DE 19714 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-01 |
| Decision Date | 2006-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768019616 | K060266 | 000 |