The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Tbi Flex And Dbi Flex Reagent Cartridges And Tbi/dbi Calibrator.
| Device ID | K060628 |
| 510k Number | K060628 |
| Device Name: | DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101 |
| Contact | George M Plummer |
| Correspondent | George M Plummer DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-09 |
| Decision Date | 2006-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768020551 | K060628 | 000 |
| 00842768020544 | K060628 | 000 |
| 00842768016813 | K060628 | 000 |