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FDA 510(k)

K-ASSAY ALPHA-1 AG

K-Number: K993441 · 1999-11-24

ApplicantKamiya Biomedical Co.
Decision Date1999-11-24
Product CodeLKL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K-ASSAY ALPHA-1 AG is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Co.. It received FDA 510(k) clearance on 1999-11-24 under 510(k) number K993441. The device is classified under product code LKL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-ASSAY ALPHA-1 AG?

K-ASSAY ALPHA-1 AG is a medical device that received FDA 510(k) clearance on 1999-11-24. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K993441.

When did K-ASSAY ALPHA-1 AG receive FDA 510(k) clearance?

K-ASSAY ALPHA-1 AG received FDA 510(k) clearance on 1999-11-24, under 510(k) number K993441.

Who is the listed applicant for K-ASSAY ALPHA-1 AG?

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

What is the FDA product code for K-ASSAY ALPHA-1 AG?

The FDA product code for K-ASSAY ALPHA-1 AG is LKL.

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Other records listing Kamiya Biomedical Co. 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.

K093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLK091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORK050944K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETK042241K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CK030687K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091CK023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

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Related Devices (Code: LKL)

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.

K964299N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.K964257IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENTBeckman Instruments, Inc.K922417AL-ACID GLYCOPROTEIN RID KITThe Binding Site, Ltd.K904175RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENTReagents Applications, Inc.K884217TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEINTechnicon Instruments Corp.K873868ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)Unipath , Ltd.

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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