Submission Details
| 510(k) Number | K111356 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 16, 2011 |
| Decision Date | November 09, 2011 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ASIMANAGER - AT
Nov 2011
Decision
177d
Days
Class 1
Risk
About This 510(k) Submission
K111356 is an FDA 510(k) clearance for the ASIMANAGER - AT, a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT), submitted by Arlington Scientific, Inc. (Springville, US). The FDA issued a Cleared decision on November 9, 2011, 177 days after receiving the submission on May 16, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2400.
Device Classification
| Product Code | JQT — Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2400 |
Manufacturer
Similar Devices — JQT Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
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