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FDA 510(k)

HEMODIALYSATE

K-Number: K813388 · 1981-12-31

ApplicantEdlaw Pharmaceuticals, Inc.
Decision Date1981-12-31
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYSATE is the device name listed in this FDA 510(k) record. The listed applicant is Edlaw Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813388. 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 HEMODIALYSATE?

HEMODIALYSATE is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Edlaw Pharmaceuticals, Inc.. The 510(k) number is K813388.

When did HEMODIALYSATE receive FDA 510(k) clearance?

HEMODIALYSATE received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813388.

Who is the listed applicant for HEMODIALYSATE?

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

What is the FDA product code for HEMODIALYSATE?

The FDA product code for HEMODIALYSATE is KPO.

Related Clinical Trials

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.

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Other records listing Edlaw Pharmaceuticals, Inc. as applicant

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.

K833896BICARBOLYTE HEMO-DIALK811706LACTIC ACID DIALYSATE ADDITIVE

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

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