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FDA 510(k)

MODIFICATION TO RAICHEM CALCIUM REAGENT

K-Number: K022049 · 2002-07-19

ApplicantHemagen Diagnostics, Inc.
Decision Date2002-07-19
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO RAICHEM CALCIUM 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 2002-07-19 under 510(k) number K022049. 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 MODIFICATION TO RAICHEM CALCIUM REAGENT?

MODIFICATION TO RAICHEM CALCIUM REAGENT is a medical device that received FDA 510(k) clearance on 2002-07-19. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K022049.

When did MODIFICATION TO RAICHEM CALCIUM REAGENT receive FDA 510(k) clearance?

MODIFICATION TO RAICHEM CALCIUM REAGENT received FDA 510(k) clearance on 2002-07-19, under 510(k) number K022049.

Who is the listed applicant for MODIFICATION TO RAICHEM CALCIUM 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 MODIFICATION TO RAICHEM CALCIUM REAGENT?

The FDA product code for MODIFICATION TO RAICHEM CALCIUM REAGENT is CJY.

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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.

K041051RAICHEM BUN RATE REAGENT (LIQUID)K041052RAICHEM GLUCOSE UV (LIQUID)K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTK031101RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERK022772RAICHEM LDL-CHOLESTEROL DIRECT 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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