Cleared Traditional

ERYTHROPOIETIN IMMUNOASSAY KIT

K932650 · Nichols Institute · Hematology
Mar 1994
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K932650 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 March 11, 1994, 282 days after receiving the submission on June 2, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7250.

Submission Details

510(k) Number K932650 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1993
Decision Date March 11, 1994
Days to Decision 282 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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