Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CRYOCHECK CLOT APCR

K-Number: K060284 · 2006-05-10

ApplicantPrecision Biologic, Inc.
Decision Date2006-05-10
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYOCHECK CLOT APCR 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 2006-05-10 under 510(k) number K060284. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOCHECK CLOT APCR?

CRYOCHECK CLOT APCR is a medical device that received FDA 510(k) clearance on 2006-05-10. The listed applicant is Precision Biologic, Inc.. The 510(k) number is K060284.

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

CRYOCHECK CLOT APCR received FDA 510(k) clearance on 2006-05-10, under 510(k) number K060284.

Who is the listed applicant for CRYOCHECK CLOT APCR?

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 APCR?

The FDA product code for CRYOCHECK CLOT APCR is GGW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Precision Biologic, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251440CRYOcheck Chromogenic Factor VIIIK222831CRYOcheck Factor VIII Deficient Plasma with VWFK214002CRYOcheck Chromogenic Factor IXK183440CRYOcheck FVIII Inhibitor KitK043571CRYOCHECK CLOT SK040987CRYOCHECK CLOT C

View all 7 devices →

Related Devices (Code: GGW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260551HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co.K090105LUPOTEK KCTR2 Diagnostics, Inc.K083729HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHENAniara Diagnostica, LLCK042762PEFAKIT APC-R FACTOR V LEIDENPentapharm , Ltd.K033471PHOSPHOLIN ES AND CALCIUM CHLORIDER2 Diagnostics, Inc.K992456GRADILEIDEN V TESTGradipore , Ltd.

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.

↑