Submission Details
| 510(k) Number | K061020 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 13, 2006 |
| Decision Date | May 10, 2006 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
May 2006
Decision
27d
Days
Class 1
Risk
About This 510(k) Submission
K061020 is an FDA 510(k) clearance for the DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on May 10, 2006, 27 days after receiving the submission on April 13, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.
Device Classification
| Product Code | CKA — Nadh Oxidation/nad Reduction, Alt/sgpt |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1030 |
Manufacturer
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