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FDA 510(k)

APPRAISE URINE MICROALBUMIN COLLECTION KIT

K-Number: K002156 · 2000-12-19

ApplicantOsborn Group, Inc.
Decision Date2000-12-19
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APPRAISE URINE MICROALBUMIN 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 2000-12-19 under 510(k) number K002156. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APPRAISE URINE MICROALBUMIN COLLECTION KIT?

APPRAISE URINE MICROALBUMIN COLLECTION KIT is a medical device that received FDA 510(k) clearance on 2000-12-19. The listed applicant is Osborn Group, Inc.. The 510(k) number is K002156.

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

APPRAISE URINE MICROALBUMIN COLLECTION KIT received FDA 510(k) clearance on 2000-12-19, under 510(k) number K002156.

Who is the listed applicant for APPRAISE URINE MICROALBUMIN 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 APPRAISE URINE MICROALBUMIN COLLECTION KIT?

The FDA product code for APPRAISE URINE MICROALBUMIN COLLECTION KIT is CGX.

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.

K993787APPRAISE-CARDIO SAMPLE COLLECTION KITK990899HEMOCHEK-A1C SAMPLE COLLECTION KITK991800HEMOCHEK URINE COLLECTION KIT

Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc.

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.

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