BINDING SITE IGG SUBLCASS OLYMPUS KITS— 510(k) K042152
Substantially EquivalentThe Binding Site
FDA 510(k) clearance K042152 for BINDING SITE IGG SUBLCASS OLYMPUS KITS, Substantially Equivalent on 2004-11-22. Applicant: The Binding Site. Device class: 2.
Clearance details
- Applicant
- The Binding Site
- Product code
- Code CFN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
Recent devices under product code CFN
view allMore clearances from The Binding Site
view all- K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
- K132555 — HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
- K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
- K100455 — SPAPLUS ANALYZER
- K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS
Recalls naming K042152
K-number listed on FDA's recall record- Z-1067-2017 — Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
- Z-1068-2017 — Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents Product Code LK009.AU
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042152.
Data sourced from openFDA. This site is unofficial and independent of the FDA.