AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA— 510(k) K022945
Substantially EquivalentHycor Biomedical, Inc.
FDA 510(k) clearance K022945 for AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA, Substantially Equivalent on 2002-12-18. Applicant: Hycor Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Hycor Biomedical, Inc.
- Product code
- Code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Garden Grove, CA, US
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