OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT— 510(k) K962582
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K962582 for OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT, Substantially Equivalent on 1996-10-18. Applicant: Olympus America, Inc.. Device class: 2.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code DBI
- Device class
- Class 2
- Regulation
- 21 CFR 866.5240
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
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