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FDA 510(k)

DIALYSATE CONCENTRATE FOR HEMODIALYSIS

K-Number: K810280 · 1981-02-19

ApplicantCobe Laboratories, Inc.
Decision Date1981-02-19
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYSATE CONCENTRATE FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1981-02-19 under 510(k) number K810280. 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 DIALYSATE CONCENTRATE FOR HEMODIALYSIS?

DIALYSATE CONCENTRATE FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 1981-02-19. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K810280.

When did DIALYSATE CONCENTRATE FOR HEMODIALYSIS receive FDA 510(k) clearance?

DIALYSATE CONCENTRATE FOR HEMODIALYSIS received FDA 510(k) clearance on 1981-02-19, under 510(k) number K810280.

Who is the listed applicant for DIALYSATE CONCENTRATE FOR HEMODIALYSIS?

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

What is the FDA product code for DIALYSATE CONCENTRATE FOR HEMODIALYSIS?

The FDA product code for DIALYSATE CONCENTRATE FOR HEMODIALYSIS 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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