510(k) K860923— EZ DETECT, 5 MINUTE STREP-A COLOR TEST

Substantially Equivalent

Self Care Systems, Inc.

Clearance details

Applicant
Self Care Systems, Inc.
Product code
Code GTZ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newport Beach, CA, US
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