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FDA 510(k)

RAICHEM CALCIUM (OCPC) LIQUID REAGENT

K-Number: K041009 · 2004-06-25

ApplicantHemagen Diagnostics, Inc.
Decision Date2004-06-25
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM CALCIUM (OCPC) LIQUID REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 2004-06-25 under 510(k) number K041009. 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 RAICHEM CALCIUM (OCPC) LIQUID REAGENT?

RAICHEM CALCIUM (OCPC) LIQUID REAGENT is a medical device that received FDA 510(k) clearance on 2004-06-25. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K041009.

When did RAICHEM CALCIUM (OCPC) LIQUID REAGENT receive FDA 510(k) clearance?

RAICHEM CALCIUM (OCPC) LIQUID REAGENT received FDA 510(k) clearance on 2004-06-25, under 510(k) number K041009.

Who is the listed applicant for RAICHEM CALCIUM (OCPC) LIQUID REAGENT?

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

What is the FDA product code for RAICHEM CALCIUM (OCPC) LIQUID REAGENT?

The FDA product code for RAICHEM CALCIUM (OCPC) LIQUID REAGENT is CIC.

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Other records listing Hemagen Diagnostics, 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.

K041052RAICHEM GLUCOSE UV (LIQUID)K041051RAICHEM BUN RATE REAGENT (LIQUID)K031101RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERK022772RAICHEM LDL-CHOLESTEROL DIRECT REAGENTK022767RAICHEM LIPID CALIBRATOR

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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.K023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORElan 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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