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FDA 510(k)

INORGANIC PHOSPHORUS ASSAY KIT

K-Number: K843030 · 1984-08-27

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-08-27
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INORGANIC PHOSPHORUS ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K843030. 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 INORGANIC PHOSPHORUS ASSAY KIT?

INORGANIC PHOSPHORUS ASSAY KIT is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K843030.

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

INORGANIC PHOSPHORUS ASSAY KIT received FDA 510(k) clearance on 1984-08-27, under 510(k) number K843030.

Who is the listed applicant for INORGANIC PHOSPHORUS ASSAY KIT?

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

What is the FDA product code for INORGANIC PHOSPHORUS ASSAY KIT?

The FDA product code for INORGANIC PHOSPHORUS ASSAY KIT is CEO.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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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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