STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR— 510(k) K133549
Substantially EquivalentSteritec Products Mfg Co, Inc.
FDA 510(k) clearance K133549 for STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, Substantially Equivalent on 2014-08-27. 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.