HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS— 510(k) K955087
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K955087 for HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS, Substantially Equivalent on 1996-06-13. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.