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FDA 510(k)

CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432

K-Number: K902479 · 1990-07-17

ApplicantAmresco, Inc.
Decision Date1990-07-17
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1990-07-17 under 510(k) number K902479. 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 REAGENT CODE 7732, 7733, 7532 & 7432?

CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is Amresco, Inc.. The 510(k) number is K902479.

When did CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 receive FDA 510(k) clearance?

CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 received FDA 510(k) clearance on 1990-07-17, under 510(k) number K902479.

Who is the listed applicant for CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432?

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

What is the FDA product code for CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432?

The FDA product code for CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 is CIC.

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Other records listing Amresco, 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.

K905618GGT REAGENTK904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176K905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116

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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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