The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for The Dimension Vista Flex Reagent Cartridges / Kit Assays.
| Device ID | K062128 |
| 510k Number | K062128 |
| Device Name: | THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
| Product Code | JHS |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LCP |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-26 |
| Decision Date | 2006-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015557 | K062128 | 000 |
| 00842768015441 | K062128 | 000 |
| 00842768015380 | K062128 | 000 |
| 00842768015359 | K062128 | 000 |
| 00842768015304 | K062128 | 000 |
| 00842768015120 | K062128 | 000 |
| 00842768015083 | K062128 | 000 |
| 00842768015076 | K062128 | 000 |
| 00842768015052 | K062128 | 000 |