IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST— 510(k) K911849
Substantially EquivalentGeneral Biometrics, Inc.
FDA 510(k) clearance K911849 for IMMUNOWELL SJOGRENS SYNDROME A (RO)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
Recent devices under product code LKO
view all- K191085 — Maverick RNP Assay and Maverick Diagnostic System
- K140224 — EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
- K123261 — EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
- K083117 — ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
- K071210 — MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
More clearances from General Biometrics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.