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FDA 510(k)

ACID CONCENTRATE SOLUTIONS

K-Number: K910319 · 1991-04-24

ApplicantBiopharm, Inc.
Decision Date1991-04-24
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACID CONCENTRATE SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Biopharm, Inc.. It received FDA 510(k) clearance on 1991-04-24 under 510(k) number K910319. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACID CONCENTRATE SOLUTIONS?

ACID CONCENTRATE SOLUTIONS is a medical device that received FDA 510(k) clearance on 1991-04-24. The listed applicant is Biopharm, Inc.. The 510(k) number is K910319.

When did ACID CONCENTRATE SOLUTIONS receive FDA 510(k) clearance?

ACID CONCENTRATE SOLUTIONS received FDA 510(k) clearance on 1991-04-24, under 510(k) number K910319.

Who is the listed applicant for ACID CONCENTRATE SOLUTIONS?

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

What is the FDA product code for ACID CONCENTRATE SOLUTIONS?

The FDA product code for ACID CONCENTRATE SOLUTIONS is KPO.

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Related Devices (Code: KPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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