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FDA 510(k)

OLYMPUS CALCIUM ARSENAZO III REAGENT

K-Number: K982035 · 1998-06-24

ApplicantOlympus Diagnostica GmbH
Decision Date1998-06-24
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS CALCIUM ARSENAZO III REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Diagnostica GmbH. It received FDA 510(k) clearance on 1998-06-24 under 510(k) number K982035. 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 OLYMPUS CALCIUM ARSENAZO III REAGENT?

OLYMPUS CALCIUM ARSENAZO III REAGENT is a medical device that received FDA 510(k) clearance on 1998-06-24. The listed applicant is Olympus Diagnostica GmbH. The 510(k) number is K982035.

When did OLYMPUS CALCIUM ARSENAZO III REAGENT receive FDA 510(k) clearance?

OLYMPUS CALCIUM ARSENAZO III REAGENT received FDA 510(k) clearance on 1998-06-24, under 510(k) number K982035.

Who is the listed applicant for OLYMPUS CALCIUM ARSENAZO III REAGENT?

The FDA 510(k) record lists Olympus Diagnostica GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS CALCIUM ARSENAZO III REAGENT?

The FDA product code for OLYMPUS CALCIUM ARSENAZO III REAGENT is CJY.

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Other records listing Olympus Diagnostica GmbH 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.

K994189OLYMPUS CREATINE KINASE REAGENT OSR6179/6279K984145OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENTK981854OLYMPUS SERUM PROTEIN MULTICALIBRATOR,

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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