IMMUNOCARD STREP A TEST— 510(k) K896109
Substantially EquivalentDisease Detection International, Inc.
FDA 510(k) clearance K896109 for IMMUNOCARD STREP A TEST, Substantially Equivalent on 1989-11-29. Applicant: Disease Detection International, Inc.. Device class: 1.
Clearance details
- Applicant
- Disease Detection International, 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
- Irvine, CA, US
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More clearances from Disease Detection International, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.