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FDA 510(k)

DRI-LYTE

K-Number: K780353 · 1978-04-05

ApplicantMallinckrodt Critical Care
Decision Date1978-04-05
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRI-LYTE is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1978-04-05 under 510(k) number K780353. 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 DRI-LYTE?

DRI-LYTE is a medical device that received FDA 510(k) clearance on 1978-04-05. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K780353.

When did DRI-LYTE receive FDA 510(k) clearance?

DRI-LYTE received FDA 510(k) clearance on 1978-04-05, under 510(k) number K780353.

Who is the listed applicant for DRI-LYTE?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRI-LYTE?

The FDA product code for DRI-LYTE 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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