AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081— 510(k) K896270
Substantially EquivalentAmersham Corp.
FDA 510(k) clearance K896270 for AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081, Substantially Equivalent on 1989-12-12. Applicant: Amersham Corp.. Device class: 1.
Clearance details
- Applicant
- Amersham Corp.
- 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
- Arlington Heights, IL, US
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