STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR— 510(k) K133322
Substantially EquivalentSteritec Products Mfg Co, Inc.
FDA 510(k) clearance K133322 for STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, Substantially Equivalent on 2014-08-25. Applicant: Steritec Products Mfg Co, Inc.. Device class: 2.
Clearance details
- Applicant
- Steritec Products Mfg Co, Inc.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Engelwood, CO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.