SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT— 510(k) K002564
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K002564 for SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT, Substantially Equivalent on 2000-10-26. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code DFH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
Recent devices under product code DFH
view all- K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
- K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
- K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
- K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
- K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
More clearances from The Binding Site, Ltd.
view all- K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
- K083289 — HUMAN BETA-2 MICROGLOBULIN KIT
- K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
- K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
- K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
Data sourced from openFDA. This site is unofficial and independent of the FDA.