Cleared Traditional

IMMUNOHEMATOLOGICAL SALINE #97139

K831200 · Emd Chemicals, Inc. · Chemistry
May 1983
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K831200 is an FDA 510(k) clearance for the IMMUNOHEMATOLOGICAL SALINE #97139, a Solution, Isotonic (Class I — General Controls, product code JCE), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983, 28 days after receiving the submission on April 11, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K831200 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1983
Decision Date May 09, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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