The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Ethyl Alcohol (alc), Alkaline Phosphatase (alp), Calcium (ca0 Flex, Lactic Acid (la) Flex Reagent Cartri.
| Device ID | K061792 |
| 510k Number | K061792 |
| Device Name: | DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI |
| Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| 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 | DIC |
| Subsequent Product Code | CIC |
| Subsequent Product Code | CJE |
| Subsequent Product Code | JIH |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015618 | K061792 | 000 |