EZ DETECT, 5 MINUTE STREP-A COLOR TEST— 510(k) K860923
Substantially EquivalentSelf Care Systems, Inc.
FDA 510(k) clearance K860923 for EZ DETECT, 5 MINUTE STREP-A COLOR TEST, Substantially Equivalent on 1986-05-16. Applicant: Self Care Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Self Care Systems, Inc.
- Product code
- Code GTZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newport Beach, CA, US
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More clearances from Self Care Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.