Stat Fax 2600

FDA 510(k) K941394 · Awareness Technology, Inc.

Substantially Equivalent

510(k) numberK941394

Submission

Device name
Stat Fax 2600
Applicant
Awareness Technology, Inc.
Palm City, FL, US
Received
March 22, 1994
Decision date
June 3, 1994
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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K970420Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional Pharmacia, Inc.06/30/1997SE
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K962859Mini Sample ProcessorJQW · Traditional Cavro Scientific Instruments, Inc.10/29/1996SE
K961896Microlab 4000, Microlab 4200JQW · Traditional Hamilton Co.08/16/1996SE
K961694ImpactJQW · Traditional Matrix Technologies Corp.06/21/1996SE
K953345GenesisJQW · Traditional Tecan U.S., Inc.11/21/1995SE

More from Tecan U.S., Inc.

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K974762Stat TracksJJQ · Traditional 01/28/1998SE
K943729Dye Check Strips 545-630JJY · Traditional 12/29/1994SE
K923598Redi-Check Photmeter Q.A.JFS · Traditional 10/14/1992SE
K900224Stat FAX(TM)-2100JJQ · Traditional 03/01/1990SE
K892656Dri-Dye Check Strips (TM)-405JJX · Traditional 05/22/1989SE
K882938Stat Fax(Tm)JJQ · Traditional 09/09/1988SE
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Questions and answers

When was Stat Fax 2600 cleared by the FDA?

Stat Fax 2600 (K941394) received a 510(k) decision of Substantially Equivalent on June 3, 1994, 73 days after the submission was received.

What is the product code of K941394?

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.