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 WEAK LUPUS POSITIVE CONTROL

K-Number: K032804 · 2003-11-03

ApplicantPrecision Biologic
Decision Date2003-11-03
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYOCHECK WEAK LUPUS POSITIVE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic. It received FDA 510(k) clearance on 2003-11-03 under 510(k) number K032804. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOCHECK WEAK LUPUS POSITIVE CONTROL?

CRYOCHECK WEAK LUPUS POSITIVE CONTROL is a medical device that received FDA 510(k) clearance on 2003-11-03. The listed applicant is Precision Biologic. The 510(k) number is K032804.

When did CRYOCHECK WEAK LUPUS POSITIVE CONTROL receive FDA 510(k) clearance?

CRYOCHECK WEAK LUPUS POSITIVE CONTROL received FDA 510(k) clearance on 2003-11-03, under 510(k) number K032804.

Who is the listed applicant for CRYOCHECK WEAK LUPUS POSITIVE CONTROL?

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

What is the FDA product code for CRYOCHECK WEAK LUPUS POSITIVE CONTROL?

The FDA product code for CRYOCHECK WEAK LUPUS POSITIVE CONTROL is GGC.

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 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.

K193556Cryocheck Hex LAK193204Cryocheck Chromogenic Factor VIIIK023991CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50K023990CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10K990580CRYOCHECK LA SURE, MODEL SUR25-10

View all 10 devices →

Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K023312CONTROL PLASMA PDade Behring, Inc.K020878LYPHOCHEK HEMOSTASIS, MODELS 798, 799Bio-Rad

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.

↑