TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION— 510(k) K981914
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K981914 for TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION, Substantially Equivalent on 1999-11-26. Applicant: The Binding Site, Ltd.. Device class: 1.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
Recent devices under product code JJX
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
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.