Cleared Traditional

PHOSPHATE BUFFERED SALINE (1X)

K811791 · Dutchland Laboratories, Inc. · Chemistry
Aug 1981
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K811791 is an FDA 510(k) clearance for the PHOSPHATE BUFFERED SALINE (1X), a Ph Buffer (Class I — General Controls, product code JCC), submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1981, 62 days after receiving the submission on June 24, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K811791 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1981
Decision Date August 25, 1981
Days to Decision 62 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