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FDA 510(k)

DRYASOL ACID CONCENTRATE MIX

K-Number: K993212 · 1999-10-22

ApplicantDiasol, Inc.
Decision Date1999-10-22
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRYASOL ACID CONCENTRATE MIX is the device name listed in this FDA 510(k) record. The listed applicant is Diasol, Inc.. It received FDA 510(k) clearance on 1999-10-22 under 510(k) number K993212. 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 DRYASOL ACID CONCENTRATE MIX?

DRYASOL ACID CONCENTRATE MIX is a medical device that received FDA 510(k) clearance on 1999-10-22. The listed applicant is Diasol, Inc.. The 510(k) number is K993212.

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

DRYASOL ACID CONCENTRATE MIX received FDA 510(k) clearance on 1999-10-22, under 510(k) number K993212.

Who is the listed applicant for DRYASOL ACID CONCENTRATE MIX?

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

What is the FDA product code for DRYASOL ACID CONCENTRATE MIX?

The FDA product code for DRYASOL ACID CONCENTRATE MIX is KPO.

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Other records listing Diasol, 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.

K020231DIASOL-ADDITIVESK020230DIASOL-BICARBK011004NEEDLELOK HYPODERMIC NEEDLE PROTECTIONK010958FISTULOK FISTULA NEEDLE PROTECTIONK011003SAFESTING AND SAFESTING HUBK993187SHELLY PROTECTED AV FISTULA NEEDLE

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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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