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FDA 510(k)

Citric Complete Dry Citric Acid (45X)

N.º K: K171750 · 2018-03-06

SolicitanteDimesol USA, LLC
Fecha de decisión2018-03-06
Código de productoKPO
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Citric Complete Dry Citric Acid (45X) is the device name listed in this FDA 510(k) record. The listed applicant is Dimesol USA, LLC. It received FDA 510(k) clearance on 2018-03-06 under 510(k) number K171750. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Citric Complete Dry Citric Acid (45X)?

Citric Complete Dry Citric Acid (45X) is a medical device that received FDA 510(k) clearance on 2018-03-06. The listed applicant is Dimesol USA, LLC. The 510(k) number is K171750.

When did Citric Complete Dry Citric Acid (45X) receive FDA 510(k) clearance?

Citric Complete Dry Citric Acid (45X) received FDA 510(k) clearance on 2018-03-06, under 510(k) number K171750.

Who is the listed applicant for Citric Complete Dry Citric Acid (45X)?

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

What is the FDA product code for Citric Complete Dry Citric Acid (45X)?

The FDA product code for Citric Complete Dry Citric Acid (45X) is KPO.

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Dispositivos relacionados (Código: KPO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedK253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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