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FDA 510(k)

WAKO(TM) MICRO-ALBUMIN

K-Number: K902216 · 1990-06-18

ApplicantWako Chemicals USA, Inc.
Decision Date1990-06-18
Product CodeJIQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO(TM) MICRO-ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Wako Chemicals USA, Inc.. It received FDA 510(k) clearance on 1990-06-18 under 510(k) number K902216. 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 WAKO(TM) MICRO-ALBUMIN?

WAKO(TM) MICRO-ALBUMIN is a medical device that received FDA 510(k) clearance on 1990-06-18. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K902216.

When did WAKO(TM) MICRO-ALBUMIN receive FDA 510(k) clearance?

WAKO(TM) MICRO-ALBUMIN received FDA 510(k) clearance on 1990-06-18, under 510(k) number K902216.

Who is the listed applicant for WAKO(TM) MICRO-ALBUMIN?

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

What is the FDA product code for WAKO(TM) MICRO-ALBUMIN?

The FDA product code for WAKO(TM) MICRO-ALBUMIN 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 Wako Chemicals USA, 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.

K100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONK080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201K080123APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATORK062368WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401K053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791

View all 123 devices →

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.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 Products

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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