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FDA 510(k)

CALCIUM ARSENAZO III REAGENT

K-Number: K903896 · 1990-09-13

ApplicantTrace Scientific , Ltd.
Decision Date1990-09-13
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM ARSENAZO III REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1990-09-13 under 510(k) number K903896. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIUM ARSENAZO III REAGENT?

CALCIUM ARSENAZO III REAGENT is a medical device that received FDA 510(k) clearance on 1990-09-13. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K903896.

When did CALCIUM ARSENAZO III REAGENT receive FDA 510(k) clearance?

CALCIUM ARSENAZO III REAGENT received FDA 510(k) clearance on 1990-09-13, under 510(k) number K903896.

Who is the listed applicant for CALCIUM ARSENAZO III REAGENT?

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

What is the FDA product code for CALCIUM ARSENAZO III REAGENT?

The FDA product code for CALCIUM ARSENAZO III REAGENT is CIC.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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Related Devices (Code: CIC)

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.

K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)Siemens Healthcare Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen Diagnostics, Inc.

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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