Cleared Traditional

SQC BUFFER

K812601 · Transidyne General Corp. · Chemistry
Oct 1981
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K812601 is an FDA 510(k) clearance for the SQC BUFFER, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Transidyne General Corp. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1981, 18 days after receiving the submission on September 14, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K812601 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1981
Decision Date October 02, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJS — Controls For Blood-gases, (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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