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FDA 510(k)

PHOSPHORUS REAGENT SET

K-Number: K823691 · 1983-01-07

ApplicantOmega Medical Electronics
Decision Date1983-01-07
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOSPHORUS REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Electronics. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823691. 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 SET?

PHOSPHORUS REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Omega Medical Electronics. The 510(k) number is K823691.

When did PHOSPHORUS REAGENT SET receive FDA 510(k) clearance?

PHOSPHORUS REAGENT SET received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823691.

Who is the listed applicant for PHOSPHORUS REAGENT SET?

The FDA 510(k) record lists Omega Medical Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOSPHORUS REAGENT SET?

The FDA product code for PHOSPHORUS REAGENT SET is CEO.

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Other records listing Omega Medical Electronics 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.

K821212UREA NITROGEN REAGENT SETK821204GLUCOSE(ENZYMATIC) REAGENT SETK821206SGPT-UV REAGENT SETK821208SGOT-UV REAGENT SETK821205TRIGLYCERIDE REAGENT SETK821201LDH-UV REAGENT SET

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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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