SIMPLEX-2— 510(k) K832541
Substantially EquivalentGentech Australia
FDA 510(k) clearance K832541 for SIMPLEX-2, Substantially Equivalent on 1984-02-04. Applicant: Gentech Australia. Device class: 2.
Clearance details
- Applicant
- Gentech Australia
- Product code
- Code GQN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.