SQC Buffer

FDA 510(k) K812601 · Transidyne General Corp.

Substantially Equivalent

510(k) numberK812601

Submission

Device name
SQC Buffer
Applicant
Transidyne General Corp.
Mchenry, IL, US
Received
September 14, 1981
Decision date
October 2, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJS – Controls For Blood-Gases, (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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K130236Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3JJS · Traditional Radiometer Medical Aps03/15/2013SE
K033063Mission ControlsJJS · Traditional Diamond Diagnostics, Inc.12/12/2003SE
K022529Liquichek Blood Gas Plus Co-Oximeter Control (Il Synthesis Series) Levels 1,2, and 3…JJS · Traditional Bio-Rad08/15/2002SE
K022525Liquichek Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3…JJS · Traditional Bio-Rad08/15/2002SE
K003242Liquichek Blood Gas Plus Co-Oximeter Control (Il), Model 621,622,623JJS · Traditional Bio-Rad11/30/2000SE
K003239Liquichek Blood Gas Plus Co-Oximeter Control (800 Series), MODEL504,505,506JJS · Traditional Bio-Rad11/30/2000SE
K002866Liquichek Blood Gas Plus E Control Level 4, Model 574JJS · Traditional Bio-Rad09/25/2000SE

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Questions and answers

When was SQC Buffer cleared by the FDA?

SQC Buffer (K812601) received a 510(k) decision of Substantially Equivalent on October 2, 1981, 18 days after the submission was received.

What is the product code of K812601?

The FDA product code is JJS – Controls For Blood-Gases, (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.