ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY— 510(k) K882740
Substantially EquivalentLipogen, Inc.
FDA 510(k) clearance K882740 for ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY, Substantially Equivalent on 1988-09-22. Applicant: Lipogen, Inc.. Device class: 2.
Clearance details
- Applicant
- Lipogen, Inc.
- Product code
- Code LKJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Knoxville, TN, US
Recent devices under product code LKJ
view all- K210902 — EliA Ro52, EliA Ro60
- K113610 — ANA-SCREEN WITH MDSS
- K082759 — ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
- K081104 — AESKULISA ANA HEP-2, REF 30-7115US
- K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
More clearances from Lipogen, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.