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FDA 510(k)

CHLORIDE TEST KIT

K-Number: K842011 · 1984-06-22

ApplicantMallinckrodt Critical Care
Decision Date1984-06-22
Product CodeCHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHLORIDE 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 1984-06-22 under 510(k) number K842011. The device is classified under product code CHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLORIDE TEST KIT?

CHLORIDE TEST KIT is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K842011.

When did CHLORIDE TEST KIT receive FDA 510(k) clearance?

CHLORIDE TEST KIT received FDA 510(k) clearance on 1984-06-22, under 510(k) number K842011.

Who is the listed applicant for CHLORIDE 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 CHLORIDE TEST KIT?

The FDA product code for CHLORIDE TEST KIT is CHJ.

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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: CHJ)

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.

K010670PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.K945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERCatachem, Inc.K943006CHLORIDE QVETPrisma SystemsK934136OLYMPUS CHLORIDE REAGENT, MODIFICATIONOlympus Corp.K932528OLYMPUS CHLORID REAGENT, MODIFIEDOlympus Corp.K925338OLYMPUS CHLORIDE REAGENTOlympus Corp.

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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