AMERLITE FSH ASSAY— 510(k) K952285
Substantially EquivalentJohnson & Johnson Clinical Diagnostics, Inc.
FDA 510(k) clearance K952285 for AMERLITE FSH ASSAY, Substantially Equivalent on 1995-07-03. Applicant: Johnson & Johnson Clinical Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
- Product code
- Code CGJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1300
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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