CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT— 510(k) K913668
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K913668 for CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT, Substantially Equivalent on 1991-12-20. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code DDB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5210
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code DDB
view allMore clearances from The Binding Site, Ltd.
view all- K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.