DIRECT TESTOSTERONE RIA— 510(k) K811536
Substantially EquivalentImmuchem Corp.
FDA 510(k) clearance K811536 for DIRECT TESTOSTERONE RIA, Substantially Equivalent on 1981-06-18. Applicant: Immuchem Corp.. Device class: 1.
Clearance details
- Applicant
- Immuchem Corp.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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