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FDA 510(k)

ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)

K-Number: K873868 · 1987-10-20

ApplicantUnipath , Ltd.
Decision Date1987-10-20
Product CodeLKL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K873868. 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 ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)?

ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Unipath , Ltd.. The 510(k) number is K873868.

When did ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) receive FDA 510(k) clearance?

ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) received FDA 510(k) clearance on 1987-10-20, under 510(k) number K873868.

Who is the listed applicant for ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)?

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

What is the FDA product code for ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)?

The FDA product code for ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) is LKL.

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Other records listing Unipath , Ltd. as applicant

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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.

K993441K-ASSAY ALPHA-1 AGKamiya Biomedical Co.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.

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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