Submission Details
| 510(k) Number | K141244 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 14, 2014 |
| Decision Date | September 09, 2014 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)
Sep 2014
Decision
118d
Days
Class 2
Risk
About This 510(k) Submission
K141244 is an FDA 510(k) clearance for the NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES), a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by North American Science Assoc., Inc. (Northwood, US). The FDA issued a Cleared decision on September 9, 2014, 118 days after receiving the submission on May 14, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.
Device Classification
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
Manufacturer
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