The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Drug Calibrator, Model Dc22b.
| Device ID | K011035 |
| 510k Number | K011035 |
| Device Name: | DIMENSION DRUG CALIBRATOR, MODEL DC22B |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101 |
| Contact | Richard M Vaught |
| Correspondent | Richard M Vaught DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-05 |
| Decision Date | 2001-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597386 | K011035 | 000 |
| 00842768005022 | K011035 | 000 |