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FDA 510(k)

PHOSPHORUS TEST KIT

K-Number: K771848 · 1977-10-28

ApplicantMallinckrodt Critical Care
Decision Date1977-10-28
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOSPHORUS 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 1977-10-28 under 510(k) number K771848. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOSPHORUS TEST KIT?

PHOSPHORUS TEST KIT is a medical device that received FDA 510(k) clearance on 1977-10-28. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K771848.

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

PHOSPHORUS TEST KIT received FDA 510(k) clearance on 1977-10-28, under 510(k) number K771848.

Who is the listed applicant for PHOSPHORUS 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 PHOSPHORUS TEST KIT?

The FDA product code for PHOSPHORUS TEST KIT is CEO.

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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: CEO)

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.

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic

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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