Cleared Traditional

PHYSIOLOGIC SALINE (0.85%)

K761174 · Bio/Data Corp. · Hematology
Jan 1977
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K761174 is an FDA 510(k) clearance for the PHYSIOLOGIC SALINE (0.85%), a Solution, Isotonic (Class I — General Controls, product code JCE), submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1977, 40 days after receiving the submission on December 1, 1976. This device falls under the Hematology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K761174 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1976
Decision Date January 10, 1977
Days to Decision 40 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