BIOCHECK IGE ELISA, MODEL BC-1035— 510(k) K992528
Substantially EquivalentBiocheck, Inc.
FDA 510(k) clearance K992528 for BIOCHECK IGE ELISA, MODEL BC-1035, Substantially Equivalent on 1999-09-21. Applicant: Biocheck, Inc.. Device class: 2.
Clearance details
- Applicant
- Biocheck, Inc.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.