WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD— 510(k) K993928
Substantially EquivalentWako Chemicals USA, Inc.
FDA 510(k) clearance K993928 for WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD, Substantially Equivalent on 2000-01-18. Applicant: Wako Chemicals USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Wako Chemicals USA, Inc.
- Product code
- Code DEW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richmond, VA, US
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