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FDA 510(k)

PHOSPHORUS REAGENT SYSTEM

K-Number: K840215 · 1984-03-19

ApplicantSclavo, Inc.
Decision Date1984-03-19
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHOSPHORUS REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K840215. 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 SYSTEM?

PHOSPHORUS REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Sclavo, Inc.. The 510(k) number is K840215.

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

PHOSPHORUS REAGENT SYSTEM received FDA 510(k) clearance on 1984-03-19, under 510(k) number K840215.

Who is the listed applicant for PHOSPHORUS REAGENT SYSTEM?

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

What is the FDA product code for PHOSPHORUS REAGENT SYSTEM?

The FDA product code for PHOSPHORUS REAGENT SYSTEM is CEO.

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Other records listing Sclavo, Inc. as applicant

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K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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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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