The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Ammonia (amon) Flex Reagent Cartridge.
| Device ID | K062316 |
| 510k Number | K062316 |
| Device Name: | DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE |
| Classification | Enzymatic Method, Ammonia |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.o. Box 6101, Newark, DE 19714 -6101 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-09 |
| Decision Date | 2006-09-06 |
| Summary: | summary |