I-ESTRIOL TEST SET— 510(k) K781599
Substantially EquivalentWien Laboratories, Inc.
FDA 510(k) clearance K781599 for I-ESTRIOL TEST SET, Substantially Equivalent on 1978-10-17. Applicant: Wien Laboratories, Inc..
Clearance details
- Applicant
- Wien Laboratories, Inc.
- Product code
- Code CGI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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