Cleared Traditional

SUPER-SPIKE TRANSFER SET

K802940 · Geneva Laboratories, Inc. · Hematology
Jan 1981
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K802940 is an FDA 510(k) clearance for the SUPER-SPIKE TRANSFER SET, a Set, Transfer (blood/plasma) (Class II — Special Controls, product code KSB), submitted by Geneva Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on January 15, 1981, 57 days after receiving the submission on November 19, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9875.

Submission Details

510(k) Number K802940 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1980
Decision Date January 15, 1981
Days to Decision 57 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KSB — Set, Transfer (blood/plasma)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.9875