FDA 510(k)

CRYOCHECK CLOT S

K-Number: K043571 · 2005-03-18

Decision Date2005-03-18

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CRYOCHECK CLOT S is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic, Inc.. It received FDA 510(k) clearance on 2005-03-18 under 510(k) number K043571. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOCHECK CLOT S?

CRYOCHECK CLOT S is a medical device that received FDA 510(k) clearance on 2005-03-18. The listed applicant is Precision Biologic, Inc.. The 510(k) number is K043571.

When did CRYOCHECK CLOT S receive FDA 510(k) clearance?

CRYOCHECK CLOT S received FDA 510(k) clearance on 2005-03-18, under 510(k) number K043571.

Who is the listed applicant for CRYOCHECK CLOT S?

The FDA 510(k) record lists Precision Biologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOCHECK CLOT S?

The FDA product code for CRYOCHECK CLOT S is GGP.

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Other records listing Precision Biologic, Inc. as applicant

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Related Devices (Code: GGP)

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company K220728vWF AgSiemens Healthcare Diagnostics Products GmbH K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO K200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

Official Source

View on FDA Database →

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