RAPID BACTERIURIA SCREENING TEST— 510(k) K820126
Substantially EquivalentAnalytical Luminescence Laboratory, Inc.
FDA 510(k) clearance K820126 for RAPID BACTERIURIA SCREENING TEST, Substantially Equivalent on 1983-01-07. Applicant: Analytical Luminescence Laboratory, Inc.. Device class: 1.
Clearance details
- Applicant
- Analytical Luminescence Laboratory, Inc.
- Product code
- Code JXA
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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