Medtec Autoblot 2000

FDA 510(k) K951753 · Medtec, Inc.

Substantially Equivalent

510(k) numberK951753

Submission

Device name
Medtec Autoblot 2000
Applicant
Medtec, Inc.
Washington, DC, US
Received
April 17, 1995
Decision date
October 17, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JQW – Station, Pipetting And Diluting, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2750
Specialty
Clinical Chemistry

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Questions and answers

When was Medtec Autoblot 2000 cleared by the FDA?

Medtec Autoblot 2000 (K951753) received a 510(k) decision of Substantially Equivalent on October 17, 1995, 183 days after the submission was received.

What is the product code of K951753?

The FDA product code is JQW – Station, Pipetting And Diluting, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2750.