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FDA 510(k)

FERRO-QUANT TM FE 59 TEST KIT

K-Number: K800868 · 1980-04-29

ApplicantMallinckrodt Critical Care
Decision Date1980-04-29
Product CodeJQG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FERRO-QUANT TM FE 59 TEST KIT 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 1980-04-29 under 510(k) number K800868. The device is classified under product code JQG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FERRO-QUANT TM FE 59 TEST KIT?

FERRO-QUANT TM FE 59 TEST KIT is a medical device that received FDA 510(k) clearance on 1980-04-29. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K800868.

When did FERRO-QUANT TM FE 59 TEST KIT receive FDA 510(k) clearance?

FERRO-QUANT TM FE 59 TEST KIT received FDA 510(k) clearance on 1980-04-29, under 510(k) number K800868.

Who is the listed applicant for FERRO-QUANT TM FE 59 TEST KIT?

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 FERRO-QUANT TM FE 59 TEST KIT?

The FDA product code for FERRO-QUANT TM FE 59 TEST KIT is JQG.

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Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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Related Devices (Code: JQG)

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.

K811954COMBO-FER IRON DIAGNOSTICImmuno Assay Corp.K800710FERRITIRON KIT CAT. #RP-1100Ria Products, Inc.K790133SPINSEP-FE59Nuclear Diagnostics, Inc.K780412TOTAL IRON BINDING CAPACITYDiagnostic Corp. of America

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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