Cleared Traditional

ISOTONIC DILUENT AF

K761182 · Central Labs. Assoc. MD Pathologists · Hematology

Dec 1976

Decision

Days

Class 1

Risk

About This 510(k) Submission

K761182 is an FDA 510(k) clearance for the ISOTONIC DILUENT AF, a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by Central Labs. Assoc. MD Pathologists (Mchenry, US). The FDA issued a Cleared decision on December 9, 1976, 7 days after receiving the submission on December 2, 1976. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number	K761182 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 1976
Decision Date	December 09, 1976
Days to Decision	7 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—