Cleared Traditional

K933934 - GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
(FDA 510(k) Clearance)

K933934 · Sigma Diagnostics, Inc. · Hematology device
Jun 1995
Decision
687d
Days
Class 2
Risk

K933934 is an FDA 510(k) clearance for the GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A. This device is classified as a Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening (Class II - Special Controls, product code JBF).

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 29, 1995, 687 days after receiving the submission on August 11, 1993.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7360.

Submission Details

510(k) Number K933934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1993
Decision Date June 29, 1995
Days to Decision 687 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JBF — Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
Device Class Class II - Special Controls
CFR Regulation 21 CFR 864.7360