The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Drug Calibrator Ii, Model Dc49c.
| Device ID | K032574 |
| 510k Number | K032574 |
| Device Name: | DIMENSION DRUG CALIBRATOR II, MODEL DC49C |
| Classification | Calibrators, Drug Mixture |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 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 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-20 |
| Decision Date | 2003-10-06 |
| Summary: | summary |