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FDA 510(k)

CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)

K-Number: K901226 · 1990-04-19

ApplicantTechnicon Instruments Corp.
Decision Date1990-04-19
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1990-04-19 under 510(k) number K901226. 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 CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)?

CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) is a medical device that received FDA 510(k) clearance on 1990-04-19. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K901226.

When did CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) receive FDA 510(k) clearance?

CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) received FDA 510(k) clearance on 1990-04-19, under 510(k) number K901226.

Who is the listed applicant for CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)?

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

What is the FDA product code for CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)?

The FDA product code for CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) is CIC.

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Other records listing Technicon Instruments Corp. as applicant

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K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

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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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