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FDA 510(k)

COBE REN NEW-D DISPENSING KIT

K-Number: K853817 · 1985-10-17

ApplicantCobe Laboratories, Inc.
Decision Date1985-10-17
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE REN NEW-D DISPENSING KIT 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 1985-10-17 under 510(k) number K853817. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE REN NEW-D DISPENSING KIT?

COBE REN NEW-D DISPENSING KIT is a medical device that received FDA 510(k) clearance on 1985-10-17. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K853817.

When did COBE REN NEW-D DISPENSING KIT receive FDA 510(k) clearance?

COBE REN NEW-D DISPENSING KIT received FDA 510(k) clearance on 1985-10-17, under 510(k) number K853817.

Who is the listed applicant for COBE REN NEW-D DISPENSING KIT?

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 COBE REN NEW-D DISPENSING KIT?

The FDA product code for COBE REN NEW-D DISPENSING KIT is LIF.

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Other records listing Cobe Laboratories, 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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Related Devices (Code: LIF)

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

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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