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FDA 510(k)

PARAMAX PHOSPHORUS REAGENT

K-Number: K833002 · 1983-10-14

ApplicantAmerican Dade
Decision Date1983-10-14
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX PHOSPHORUS REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K833002. 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 PARAMAX PHOSPHORUS REAGENT?

PARAMAX PHOSPHORUS REAGENT is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is American Dade. The 510(k) number is K833002.

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

PARAMAX PHOSPHORUS REAGENT received FDA 510(k) clearance on 1983-10-14, under 510(k) number K833002.

Who is the listed applicant for PARAMAX PHOSPHORUS REAGENT?

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

What is the FDA product code for PARAMAX PHOSPHORUS REAGENT?

The FDA product code for PARAMAX PHOSPHORUS REAGENT is CEO.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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