SICKLE-HEME A/S CONTROLS & A/A CONTROL— 510(k) K831871
Substantially EquivalentAnco Medical Reagents & Assoc.
FDA 510(k) clearance K831871 for SICKLE-HEME A/S CONTROLS & A/A CONTROL, Substantially Equivalent on 1983-07-28. Applicant: Anco Medical Reagents & Assoc.. Device class: 2.
Clearance details
- Applicant
- Anco Medical Reagents & Assoc.
- Product code
- Code GHM
- Device class
- Class 2
- Regulation
- 21 CFR 864.7825
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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