Cleared Traditional

CYMET-PLUS

K771716 · J.T. Baker Chemical Co. · Hematology
Sep 1977
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K771716 is an FDA 510(k) clearance for the CYMET-PLUS, a Cyanomethemoglobin (Class II — Special Controls, product code GKK), submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1977, 8 days after receiving the submission on September 12, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K771716 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1977
Decision Date September 20, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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