LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM— 510(k) K894252
Substantially EquivalentBio-Rad
FDA 510(k) clearance K894252 for LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM, Substantially Equivalent on 1989-08-01. Applicant: Bio-Rad. Device class: 1.
Clearance details
- Applicant
- Bio-Rad
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hercules, CA, US
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