Submission Details
| 510(k) Number | K061655 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 13, 2006 |
| Decision Date | July 10, 2006 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
DIMENSION VISTA FLEX REAGENT CARTRIDGES
Jul 2006
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
K061655 is an FDA 510(k) clearance for the DIMENSION VISTA FLEX REAGENT CARTRIDGES, a Colorimetry, Acetaminophen (Class II — Special Controls, product code LDP), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 10, 2006, 27 days after receiving the submission on June 13, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3030.
Device Classification
| Product Code | LDP — Colorimetry, Acetaminophen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3030 |
Manufacturer
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