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FDA 510(k)

PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION

K-Number: K870368 · 1987-08-19

ApplicantTrace Scientific , Ltd.
Decision Date1987-08-19
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1987-08-19 under 510(k) number K870368. 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 REAGENT-DIRECT UV METHOD W/O REDUCTION?

PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION is a medical device that received FDA 510(k) clearance on 1987-08-19. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K870368.

When did PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION receive FDA 510(k) clearance?

PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION received FDA 510(k) clearance on 1987-08-19, under 510(k) number K870368.

Who is the listed applicant for PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION?

The FDA product code for PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION is CEO.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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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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