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FDA 510(k)

CALCIUM, AZO DYE REAGENT

K-Number: K040972 · 2004-12-27

ApplicantGenchem, Inc.
Decision Date2004-12-27
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALCIUM, AZO DYE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Genchem, Inc.. It received FDA 510(k) clearance on 2004-12-27 under 510(k) number K040972. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALCIUM, AZO DYE REAGENT?

CALCIUM, AZO DYE REAGENT is a medical device that received FDA 510(k) clearance on 2004-12-27. The listed applicant is Genchem, Inc.. The 510(k) number is K040972.

When did CALCIUM, AZO DYE REAGENT receive FDA 510(k) clearance?

CALCIUM, AZO DYE REAGENT received FDA 510(k) clearance on 2004-12-27, under 510(k) number K040972.

Who is the listed applicant for CALCIUM, AZO DYE REAGENT?

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

What is the FDA product code for CALCIUM, AZO DYE REAGENT?

The FDA product code for CALCIUM, AZO DYE REAGENT is CJY.

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Other records listing Genchem, 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.

K090283CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3K040977GENCHEM ELECTROLYTE BUFFERK040973BUN REAGENTK040975GENCHEM CO2 ACID REAGENTK040974GLUCOSE OXIDASE, GLUCOSEK040976GENCHEM CREATININE REAGENT

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Related Devices (Code: CJY)

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.

K244042Calcium2Abbott IrelandK191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHORIBA ABX SASK182042Randox Calcium (Ca)Randox Laboratories, Ltd.K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTHORIBA ABX SASK120626EON CALCIUM REGENTVital Diagnostics (Manufacturing) PtyltdK083386ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)Siemens Healthcare Diagnostics

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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