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FDA 510(k)

CALCIUM REAGENT SET

K-Number: K880845 · 1988-04-05

ApplicantTech-Neal Scientific, Inc.
Decision Date1988-04-05
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Neal Scientific, Inc.. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K880845. 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 SET?

CALCIUM REAGENT SET is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Tech-Neal Scientific, Inc.. The 510(k) number is K880845.

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

CALCIUM REAGENT SET received FDA 510(k) clearance on 1988-04-05, under 510(k) number K880845.

Who is the listed applicant for CALCIUM REAGENT SET?

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

What is the FDA product code for CALCIUM REAGENT SET?

The FDA product code for CALCIUM REAGENT SET is CIC.

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Other records listing Tech-Neal Scientific, 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.

K882256MAGNESIUM REAGENT SETK882459DIAZO, COLORIMETRIC BILIRUBINK881239GAMMA GLUTAMYL TRANSFERASE REAGENT SETK881241TOTAL BILIRUBIN REAGENTK881240CHLORIDE REAGENT SETK880237CHOLESTEROL

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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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