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Data / Medical devices / Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control (LKL): 17 FDA-registered makers in 8 countries

17 establishments in 8 countries are registered with the FDA to make Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control (product code LKL, Class 1, 21 CFR 866.5420). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on November 24, 1999, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
LKL
Device class
1
Regulation
866.5420
Medical specialty
Immunology

Makers by country

CountryMakers
United States5
United Kingdom4
China2
Germany2
Spain1
Ireland1
Japan1
Italy1

Makers of Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1March 24, 1997000api.fda.gov
Kamiya Biomedical Company LLCTukwila, WA, United StatesManufacturer1November 24, 1999000api.fda.gov
Kent Laboratories, Inc.Bellingham, WA, United StatesManufacturer1July 19, 1983000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
Biokit S.A.LLISSA D AMUNT Barcelona, SpainExporter to the US, Repackager or relabeler, Specification developer0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandManufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaManufacturer0000api.fda.gov
Nittobo Medical Co., Ltd. Medical Development CenterKoriyama Fukushima, JapanContract manufacturer0000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer0000api.fda.gov
Randox Laboratories LimitedANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer0000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Sentinel CH. SPAMilano, ItalyManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer0000api.fda.gov
The Binding SiteKings Norton Birmingham, United KingdomManufacturer0000api.fda.gov
The Binding Site Group Ltd.Birmingham, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov

Updated November 24, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.