Cleared Traditional

ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY

K980737 · Nichols Institute Diagnostics · Hematology
Mar 1999
Decision
391d
Days
Class 2
Risk

About This 510(k) Submission

K980737 is an FDA 510(k) clearance for the ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY, a Assay, Erythropoietin (Class II — Special Controls, product code GGT), submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on March 23, 1999, 391 days after receiving the submission on February 25, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7250.

Submission Details

510(k) Number K980737 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1998
Decision Date March 23, 1999
Days to Decision 391 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGT — Assay, Erythropoietin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7250

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