IMMUNOWELL BORRELIA (LYME)TEST— 510(k) K911590
Substantially EquivalentGeneral Biometrics, Inc.
FDA 510(k) clearance K911590 for IMMUNOWELL BORRELIA (LYME)TEST, Substantially Equivalent on 1991-12-20. Applicant: General Biometrics, Inc.. Device class: 2.
Clearance details
- Applicant
- General Biometrics, Inc.
- 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
- San Diego, CA, US
Recent devices under product code LSR
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view allRecalls naming K911590
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911590.
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