Cleared Traditional

UNIPAK HEMOGLOBIN

K771090 · Harleco · Chemistry
Jul 1977
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K771090 is an FDA 510(k) clearance for the UNIPAK HEMOGLOBIN, a Cyanomethemoglobin (Class II — Special Controls, product code GKK), submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977, 25 days after receiving the submission on June 16, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K771090 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1977
Decision Date July 11, 1977
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code GKK — Cyanomethemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7500