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Data / Medical devices / Formulations, Balanced Salt Solutions

Formulations, Balanced Salt Solutions (KIP): 19 FDA-registered makers in 6 countries

19 establishments in 6 countries are registered with the FDA to make Formulations, Balanced Salt Solutions (product code KIP, Class 1, 21 CFR 864.2875). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on March 30, 1987, 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
KIP
Device class
1
Regulation
864.2875
Medical specialty
Hematology

Makers by country

CountryMakers
United States8
China6
India2
United Kingdom1
Belgium1
Israel1

Makers of Formulations, Balanced Salt Solutions

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
Chengdu Lanrun Biotechnology Co.,ltdChengdu Sichuan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Clinical Diagnostic Solutions, Inc.Plantation, FL, United StatesManufacturer0000api.fda.gov
FBGC LimitedBridlington East Riding of Yorkshire, United KingdomForeign private label distributor, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Gemini Bioproducts LLCWest Sacramento, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Himedia Laboratories Private LimitedDOMBIVLI, THANE Maharashtra, IndiaManufacturer0000api.fda.gov
Himedia Laboratories Private LimitedNASHIK Maharashtra, IndiaManufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer0000api.fda.gov
Incell Corporation, LLCSan Antonio, TX, United StatesManufacturer0000api.fda.gov
Jiangsu Senwo Medical Technology Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Lonza Walkersville, Inc.Walkersville, MD, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Lonza Verviers SRL.Verviers Liege, BelgiumContract manufacturer0000api.fda.gov
Mainiusi Intelligent Medical Technology (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Medical Electronic Systems Ltd.CAESAREA IND. PARK Haifa, IsraelManufacturer0000api.fda.gov
Medico Technology Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Newcomer Supply IncWaunakee, WI, United StatesSpecification developer0000api.fda.gov
Ningbo Chiwell Biotechnology Co.,ltdNingbo Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Athens, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Reprocessing Products Corporation (RPC)Tucson, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Wuhan Landing Intelligence Medical Co.,LtdWuhan Hubei, ChinaManufacturer0000api.fda.gov

Updated March 30, 1987. 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.