Cleared Traditional

CITRATE BUFFER

K811251 · Bioscientific · Chemistry
May 1981
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K811251 is an FDA 510(k) clearance for the CITRATE BUFFER, a Ph Buffer (Class I — General Controls, product code JCC), submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981, 16 days after receiving the submission on May 5, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K811251 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1981
Decision Date May 21, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JCC — Ph Buffer
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010