Data / Medical devices / Acid, Lactic, Enzymatic Method / United States

FDA-registered makers of Acid, Lactic, Enzymatic Method in the United States: 19 establishments

Name: FDA-registered makers of Acid, Lactic, Enzymatic Method in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

19 establishments in the United States are registered with the FDA to make Acid, Lactic, Enzymatic Method (product code KHP). 6 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device: Acid, Lactic, Enzymatic Method
Product code: KHP
Country: United States

Makers of Acid, Lactic, Enzymatic Method in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Nova Biomedical Corporation	Waltham, MA, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer	2	January 5, 2012	0	api.fda.gov
Nova Biomedical Corporation Diabetes Products	Billerica, MA, United States	Complaint file establishment, Manufacturer	2	January 5, 2012	0	api.fda.gov
Nova Biomedical Corporation	Billerica, MA, United States	Complaint file establishment, Manufacturer, Remanufacturer	2	January 5, 2012	0	api.fda.gov
Abaxis, Inc.	Union City, CA, United States	Manufacturer	1	March 11, 2013	0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Newark, DE, United States	Manufacturer, Specification developer	1	November 27, 1991	0	api.fda.gov
Siemens Healthcare Diagnostics Inc	East Walpole, MA, United States	Complaint file establishment, Specification developer	1	May 3, 2012	4	api.fda.gov
Abbott Point Of Care Inc.	Princeton, NJ, United States	Complaint file establishment, Manufacturer, Specification developer	0		1	api.fda.gov
Bionostics, Inc.	Devens, MA, United States	Contract manufacturer	0		0	api.fda.gov
Fisher Diagnostics	Middletown, VA, United States	Manufacturer, Manufacturer for export	0		0	api.fda.gov
High Technology, Inc.	North Attleboro, MA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Instrumentation Laboratory Co.	Bedford, MA, United States	Manufacturer	0		0	api.fda.gov
Instrumentation Laboratory Co.	Orangeburg, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Nova Biomedical Corporation	Billerica, MA, United States	Manufacturer, Remanufacturer	0		0	api.fda.gov
Opti Medical Systems Inc.	Roswell, GA, United States	Manufacturer	0		0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Complaint file establishment, Specification developer	0		2	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Manufacturer	0		0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	E Walpole, MA, United States	Manufacturer	0		0	api.fda.gov
Ysi Incorporated	Yellow Spgs, OH, United States	Complaint file establishment, Manufacturer	0		0	api.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.