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FDA 510(k)

SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT

K-Number: K971363 · 1997-04-21

ApplicantCarolina Liquid Chemistries Corp.
Decision Date1997-04-21
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corp.. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K971363. 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 SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT?

SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Carolina Liquid Chemistries Corp.. The 510(k) number is K971363.

When did SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT receive FDA 510(k) clearance?

SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT received FDA 510(k) clearance on 1997-04-21, under 510(k) number K971363.

Who is the listed applicant for SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT?

The FDA 510(k) record lists Carolina Liquid Chemistries Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT?

The FDA product code for SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT is CEO.

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Other records listing Carolina Liquid Chemistries Corp. 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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemK972073TOTAL BILIRUBIN REAGENTK971907CALCIUM REAGENTK971324TRIGLYCERIDES, TG, OR TRIGK971967BUNK971908CREA OR CREATININE

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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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