Cleared Traditional

CERTIFIED BLOOD BANK SALINE

K801506 · Nobel Scientific Industries, Inc. · Hematology
Jul 1980
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K801506 is an FDA 510(k) clearance for the CERTIFIED BLOOD BANK SALINE, a Solution, Isotonic (Class I — General Controls, product code JCE), submitted by Nobel Scientific Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 28 days after receiving the submission on June 30, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K801506 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1980
Decision Date July 28, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JCE — Solution, Isotonic
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010