K070419 is an FDA 510(k) clearance for the OPACIDEN OPA REAGENT STRIPS. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Hach Company (Elkhart, US). The FDA issued a Cleared decision on August 31, 2007, 199 days after receiving the submission on February 13, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K070419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2007 |
| Decision Date | August 31, 2007 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |