STANBIO PROSTATIC ACID PHOSPHATASE TEST— 510(k) K800693
Substantially EquivalentStanbio Laboratory
FDA 510(k) clearance K800693 for STANBIO PROSTATIC ACID PHOSPHATASE TEST, Substantially Equivalent on 1980-04-16. Applicant: Stanbio Laboratory. Device class: 2.
Clearance details
- Applicant
- Stanbio Laboratory
- Product code
- Code CKE
- Device class
- Class 2
- Regulation
- 21 CFR 862.1020
- Advisory panel
- Clinical Chemistry
- 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.