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FDA 510(k)

AMRESCO CALCIUM REAGENT SET

K-Number: K852657 · 1985-07-15

ApplicantAmerican Research Products Co.
Decision Date1985-07-15
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMRESCO CALCIUM REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is American Research Products Co.. It received FDA 510(k) clearance on 1985-07-15 under 510(k) number K852657. 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 AMRESCO CALCIUM REAGENT SET?

AMRESCO CALCIUM REAGENT SET is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is American Research Products Co.. The 510(k) number is K852657.

When did AMRESCO CALCIUM REAGENT SET receive FDA 510(k) clearance?

AMRESCO CALCIUM REAGENT SET received FDA 510(k) clearance on 1985-07-15, under 510(k) number K852657.

Who is the listed applicant for AMRESCO CALCIUM REAGENT SET?

The FDA 510(k) record lists American Research Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMRESCO CALCIUM REAGENT SET?

The FDA product code for AMRESCO CALCIUM REAGENT SET is CIC.

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Other records listing American Research Products Co. 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.

K942984BUN REAGENTK901527BIURET (COLORMETRIC), TOTAL PROTEINK901960IRON REAGENTS PRODUCT CODES 7725 AND 7726K901964PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463K900827COLORIMETRIC CHLORIDE PRODUCT #4314125K901702NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522

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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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