The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp Control Low, Hscrp 1 Control High.
| Device ID | K061802 |
| 510k Number | K061802 |
| Device Name: | DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH |
| Classification | Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | NQD |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-27 |
| Decision Date | 2006-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006135 | K061802 | 000 |
| 00842768006432 | K061802 | 000 |
| 00842768006425 | K061802 | 000 |