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FDA 510(k)

HEMOCHEK URINE COLLECTION KIT

K-Number: K991800 · 1999-09-24

ApplicantOsborn Group, Inc.
Decision Date1999-09-24
Product CodeJIQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMOCHEK URINE COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Osborn Group, Inc.. It received FDA 510(k) clearance on 1999-09-24 under 510(k) number K991800. The device is classified under product code JIQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHEK URINE COLLECTION KIT?

HEMOCHEK URINE COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Osborn Group, Inc.. The 510(k) number is K991800.

When did HEMOCHEK URINE COLLECTION KIT receive FDA 510(k) clearance?

HEMOCHEK URINE COLLECTION KIT received FDA 510(k) clearance on 1999-09-24, under 510(k) number K991800.

Who is the listed applicant for HEMOCHEK URINE COLLECTION KIT?

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

What is the FDA product code for HEMOCHEK URINE COLLECTION KIT?

The FDA product code for HEMOCHEK URINE COLLECTION KIT is JIQ.

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 Osborn Group, 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.

K002156APPRAISE URINE MICROALBUMIN COLLECTION KITK993787APPRAISE-CARDIO SAMPLE COLLECTION KITK990899HEMOCHEK-A1C SAMPLE COLLECTION KIT

Related Devices (Code: JIQ)

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.

K013643AUSAM TOTAL ALBUMIN ASSAYAusam Biotecthnologies, Inc.K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITDiagnostic SpecialtiesK965035IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENTBeckman Instruments, Inc.K944664WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATORWako Chemicals USA, Inc.K936202URINARY ALBUMIN TEST PACKDupont Medical ProductsK935662SYNERMED IR 500 CHEMISTRY ANALYZERSynermed, Inc.

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.

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