Cleared Traditional

KVM HEMOGLOBIN LYSING REAGENT

K883991 · Kvm Technologies, Inc. · Hematology

Oct 1988

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K883991 is an FDA 510(k) clearance for the KVM HEMOGLOBIN LYSING REAGENT, a Products, Red-cell Lysing Products (Class I — General Controls, product code GGK), submitted by Kvm Technologies, Inc. (Houston, US). The FDA issued a Cleared decision on October 12, 1988, 22 days after receiving the submission on September 20, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8540.

Submission Details

510(k) Number	K883991 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 1988
Decision Date	October 12, 1988
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—