MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT— 510(k) K896641
Substantially EquivalentMedix Biotech, Inc.
FDA 510(k) clearance K896641 for MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT, Substantially Equivalent on 1989-12-27. Applicant: Medix Biotech, Inc.. Device class: 1.
Clearance details
- Applicant
- Medix Biotech, Inc.
- Product code
- Code CFT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1625
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
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