Cleared Traditional

HEMOGLOBIN

K883683 · Tech-Co, Inc. · Hematology
Oct 1988
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K883683 is an FDA 510(k) clearance for the HEMOGLOBIN, a Cyanomethemoglobin Reagent And Standard Solution (Class II — Special Controls, product code GJZ), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on October 6, 1988, 38 days after receiving the submission on August 29, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K883683 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1988
Decision Date October 06, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GJZ — Cyanomethemoglobin Reagent And Standard Solution
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7500