LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)— 510(k) K971007
Substantially EquivalentMrl Diagnostics
FDA 510(k) clearance K971007 for LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M), Substantially Equivalent on 1998-06-01. Applicant: Mrl Diagnostics. Device class: 2.
Clearance details
- Applicant
- Mrl Diagnostics
- Product code
- Code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.