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FDA 510(k)

AUSAM TOTAL ALBUMIN ASSAY

K-Number: K013643 · 2003-08-14

ApplicantAusam Biotecthnologies, Inc.
Decision Date2003-08-14
Product CodeJIQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUSAM TOTAL ALBUMIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ausam Biotecthnologies, Inc.. It received FDA 510(k) clearance on 2003-08-14 under 510(k) number K013643. 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 AUSAM TOTAL ALBUMIN ASSAY?

AUSAM TOTAL ALBUMIN ASSAY is a medical device that received FDA 510(k) clearance on 2003-08-14. The listed applicant is Ausam Biotecthnologies, Inc.. The 510(k) number is K013643.

When did AUSAM TOTAL ALBUMIN ASSAY receive FDA 510(k) clearance?

AUSAM TOTAL ALBUMIN ASSAY received FDA 510(k) clearance on 2003-08-14, under 510(k) number K013643.

Who is the listed applicant for AUSAM TOTAL ALBUMIN ASSAY?

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

What is the FDA product code for AUSAM TOTAL ALBUMIN ASSAY?

The FDA product code for AUSAM TOTAL ALBUMIN ASSAY is JIQ.

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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.

K991800HEMOCHEK URINE COLLECTION KITOsborn Group, 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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