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Data / Medical devices / Enzyme Immunoassay, Phencyclidine / United States

FDA-registered makers of Enzyme Immunoassay, Phencyclidine in the United States: 35 establishments

35 establishments in the United States are registered with the FDA to make Enzyme Immunoassay, Phencyclidine (product code LCM). 20 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Enzyme Immunoassay, Phencyclidine
Product code
LCM
Country
United States

Makers of Enzyme Immunoassay, Phencyclidine in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Microgenics CorporationFremont, CA, United StatesContract manufacturer, Manufacturer3April 8, 2011000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer3May 15, 2001000api.fda.gov
Alfa Scientific Designs, Inc.Poway, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler2May 29, 2001000api.fda.gov
Alere San Diego, Inc.Pomona, CA, United StatesManufacturer, Manufacturer for export2April 20, 2021000api.fda.gov
Omega Laboratories, Inc.Mogadore, OH, United StatesManufacturer2June 25, 2013000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2January 27, 2000000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesSpecification developer1August 9, 2001000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1December 7, 1994000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesSpecification developer1August 9, 2001000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer1May 29, 2001000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler1August 9, 2001000api.fda.gov
Lin-Zhi International, Inc.Santa Clara, CA, United StatesManufacturer1May 10, 2002000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer1September 28, 2000000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer1September 28, 2000000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1November 22, 2006000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1November 22, 2006000api.fda.gov
Phamatech Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler1February 4, 1998000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer1May 31, 1996000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer1May 31, 1996000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer1May 31, 1996000api.fda.gov
ABOUND Diagnostics, IncSan Diego, CA, United StatesSpecification developer0000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Advin Biotech, Inc.San Diego, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Ark Diagnostics IncFremont, CA, United StatesManufacturer for export0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Calbiotech, Inc.El Cajon, CA, United StatesManufacturer for export, Repackager or relabeler0000api.fda.gov
Chemtron Biotech, Inc.San Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Keva Inc.Blaine, WA, United StatesManufacturer for export0000api.fda.gov
Lumiquick Diagnostics, Inc.Santa Clara, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medical Disposables CorpOrlando, FL, United StatesComplaint file establishment, Manufacturer for export, Repackager or relabeler0000api.fda.gov
Nano-Ditech CorporationCranbury, NJ, United StatesManufacturer0000api.fda.gov
Premier Biotech, LLCMinneapolis, MN, United StatesComplaint file establishment, Manufacturer for export, Specification developer0000api.fda.gov
Ucp Biosciences, Inc.Milpitas, CA, United StatesSpecification developer0000api.fda.gov
W.H.P.M., Inc.Irwindale, CA, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. 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.