Cleared Traditional

ERYTHROPOIETIN IMMUNOASSAY KIT

K952559 · Nichols Institute · Hematology
May 1996
Decision
362d
Days
Class 2
Risk

About This 510(k) Submission

K952559 is an FDA 510(k) clearance for the ERYTHROPOIETIN IMMUNOASSAY KIT, a Assay, Erythropoietin (Class II — Special Controls, product code GGT), submitted by Nichols Institute (San Juan Capistrano, US). The FDA issued a Cleared decision on May 29, 1996, 362 days after receiving the submission on June 2, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7250.

Submission Details

510(k) Number K952559 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1995
Decision Date May 29, 1996
Days to Decision 362 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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

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