FDA 510(k)

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

K-Number: K071319 · 2007-06-26

Decision Date2007-06-26

Product CodeGGN

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad, Diagnostics Grp.. It received FDA 510(k) clearance on 2007-06-26 under 510(k) number K071319. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02?

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 is a medical device that received FDA 510(k) clearance on 2007-06-26. The listed applicant is Bio-Rad, Diagnostics Grp.. The 510(k) number is K071319.

When did I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 receive FDA 510(k) clearance?

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 received FDA 510(k) clearance on 2007-06-26, under 510(k) number K071319.

Who is the listed applicant for I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02?

The FDA 510(k) record lists Bio-Rad, Diagnostics Grp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02?

The FDA product code for I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 is GGN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.