Cleared Traditional

PROTEIN-BOUND GLUCOSE ASSAYN KIT

K930823 · Diagnostic Specialties · Hematology
Aug 1993
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K930823 is an FDA 510(k) clearance for the PROTEIN-BOUND GLUCOSE ASSAYN KIT, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Diagnostic Specialties (Metuchen, US). The FDA issued a Cleared decision on August 19, 1993, 183 days after receiving the submission on February 17, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K930823 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 1993
Decision Date August 19, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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