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FDA 510(k)

CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL

K-Number: K912027 · 1992-01-30

ApplicantEnzyme Technology, Inc.
Decision Date1992-01-30
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Enzyme Technology, Inc.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K912027. 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, UNIVERSAL?

CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Enzyme Technology, Inc.. The 510(k) number is K912027.

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

CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL received FDA 510(k) clearance on 1992-01-30, under 510(k) number K912027.

Who is the listed applicant for CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL?

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

What is the FDA product code for CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL?

The FDA product code for CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL is CIC.

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Other records listing Enzyme Technology, Inc. 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.

K912028URIC ACID (URICASE) REAGENT, UNIVERSALK905227GLUCOSE (HK) REAGENT, UNIVERSALK905226TRIGLYCERIDE (GPO) REAGENT, UNIVERSALK896073CHOLESTEROL, UNIVERSAL ET

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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