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FDA 510(k)

SODIUM BICARBONATE, U.S.P.

K-Number: K891159 · 1989-04-07

ApplicantWilliams Medical Co.
Decision Date1989-04-07
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SODIUM BICARBONATE, U.S.P. is the device name listed in this FDA 510(k) record. The listed applicant is Williams Medical Co.. It received FDA 510(k) clearance on 1989-04-07 under 510(k) number K891159. 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 SODIUM BICARBONATE, U.S.P.?

SODIUM BICARBONATE, U.S.P. is a medical device that received FDA 510(k) clearance on 1989-04-07. The listed applicant is Williams Medical Co.. The 510(k) number is K891159.

When did SODIUM BICARBONATE, U.S.P. receive FDA 510(k) clearance?

SODIUM BICARBONATE, U.S.P. received FDA 510(k) clearance on 1989-04-07, under 510(k) number K891159.

Who is the listed applicant for SODIUM BICARBONATE, U.S.P.?

The FDA 510(k) record lists Williams Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SODIUM BICARBONATE, U.S.P.?

The FDA product code for SODIUM BICARBONATE, U.S.P. 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Williams Medical Co. 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.

K854031SNAP-LOCK ADDITIVE CAP #SL100K854033SNAP-LOCK ADDITIVE CAP #SL400K854034SNAP-LOCK ADDITIVE CAP #SL 300K854032SNAP-LOCK ADDITIVE CAP #SL 200

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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