OPUS ESTRADIOL— 510(k) K933066
Substantially EquivalentPb Diagnostic Systems, Inc.
FDA 510(k) clearance K933066 for OPUS ESTRADIOL, Substantially Equivalent on 1993-09-08. Applicant: Pb Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Pb Diagnostic Systems, Inc.
- Product code
- Code CHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westwood, MA, US
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More clearances from Pb Diagnostic Systems, Inc.
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