IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS— 510(k) K982100

Name: FDA 510(k) clearance K982100
Creator: U.S. Food and Drug Administration
Published: 1999-12-20

Substantially Equivalent

The Binding Site, Ltd.

FDA 510(k) clearance K982100 for IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS, Substantially Equivalent on 1999-12-20. Applicant: The Binding Site, Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site, Ltd.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1998-06-15
Decision date: 1999-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K982100

K-number listed on FDA's recall record

Z-1073-2017 — MininephThl Human lgG4 Kit Product Code: ZK009.LR 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 agentsClass II·Terminated·The Binding Site Group, Ltd.·20140911

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982100.

Data sourced from openFDA. This site is unofficial and independent of the FDA.