The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino Transferase.
| Device ID | K061020 |
| 510k Number | K061020 |
| Device Name: | DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | DADE BEHRING, INC. BLDG 500; M.S. 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. BLDG 500; M.S. 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | CKA |
| Subsequent Product Code | CIT |
| Subsequent Product Code | JMO |
| Subsequent Product Code | KLT |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015595 | K061020 | 000 |
| 00842768015137 | K061020 | 000 |
| 00842768015021 | K061020 | 000 |
| 00842768015465 | K061020 | 000 |