IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST— 510(k) K911850
Substantially EquivalentGeneral Biometrics, Inc.
FDA 510(k) clearance K911850 for IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST, Substantially Equivalent on 1991-05-07. Applicant: General Biometrics, Inc.. Device class: 2.
Clearance details
- Applicant
- General Biometrics, Inc.
- Product code
- Code LKO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from General Biometrics, Inc.
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