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FDA 510(k)

ICHEM 100 URINE CHEMISTRY ANALYZER

K-Number: K060280 · 2006-06-13

ApplicantIris International, Inc.
Decision Date2006-06-13
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ICHEM 100 URINE CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Iris International, Inc.. It received FDA 510(k) clearance on 2006-06-13 under 510(k) number K060280. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICHEM 100 URINE CHEMISTRY ANALYZER?

ICHEM 100 URINE CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 2006-06-13. The listed applicant is Iris International, Inc.. The 510(k) number is K060280.

When did ICHEM 100 URINE CHEMISTRY ANALYZER receive FDA 510(k) clearance?

ICHEM 100 URINE CHEMISTRY ANALYZER received FDA 510(k) clearance on 2006-06-13, under 510(k) number K060280.

Who is the listed applicant for ICHEM 100 URINE CHEMISTRY ANALYZER?

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

What is the FDA product code for ICHEM 100 URINE CHEMISTRY ANALYZER?

The FDA product code for ICHEM 100 URINE CHEMISTRY ANALYZER is JIL.

Related Clinical Trials

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Other records listing Iris International, 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.

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Related Devices (Code: JIL)

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.

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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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