Simplexa GBS Direct, Simplexa GBS Positive Control Pack— 510(k) K182467
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K182467 for Simplexa GBS Direct, Simplexa GBS Positive Control Pack, Substantially Equivalent on 2018-11-07. Applicant: Diasorin Molecular, LLC. Device class: 1.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code NJR
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.