The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Flex Reagent Cartridges.
| Device ID | K061655 |
| 510k Number | K061655 |
| Device Name: | DIMENSION VISTA FLEX REAGENT CARTRIDGES |
| Classification | Colorimetry, Acetaminophen |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG.500 M.S. 514; PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG.500 M.S. 514; PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | LDP |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CHH |
| Subsequent Product Code | DIH |
| Subsequent Product Code | DKJ |
| Subsequent Product Code | JFJ |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JHS |
| Subsequent Product Code | JQB |
| Subsequent Product Code | KLI |
| Subsequent Product Code | KLR |
| Subsequent Product Code | KNK |
| Subsequent Product Code | LAR |
| Subsequent Product Code | LBS |
| Subsequent Product Code | LCR |
| Subsequent Product Code | LEG |
| Subsequent Product Code | LEH |
| Subsequent Product Code | MRR |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-13 |
| Decision Date | 2006-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015663 | K061655 | 000 |
| 00842768015229 | K061655 | 000 |
| 00842768015267 | K061655 | 000 |
| 00842768015373 | K061655 | 000 |
| 00842768015489 | K061655 | 000 |
| 00842768015519 | K061655 | 000 |
| 00842768015700 | K061655 | 000 |
| 00842768015014 | K061655 | 000 |
| 00842768015069 | K061655 | 000 |
| 00842768015281 | K061655 | 000 |
| 00842768015403 | K061655 | 000 |
| 00842768015427 | K061655 | 000 |
| 00842768015434 | K061655 | 000 |
| 00842768015472 | K061655 | 000 |
| 00842768015526 | K061655 | 000 |
| 00842768015533 | K061655 | 000 |
| 00842768015090 | K061655 | 000 |