QUIDEL GROUP B STREP TEST— 510(k) K896265
Substantially EquivalentQuidel Corp.
FDA 510(k) clearance K896265 for QUIDEL GROUP B STREP TEST, Substantially Equivalent on 1990-02-16. Applicant: Quidel Corp.. Device class: 1.
Clearance details
- Applicant
- Quidel Corp.
- 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
- San Diego, CA, US
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More clearances from Quidel Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.