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FDA 510(k)

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)

K-Number: K130141 · 2013-03-22

ApplicantHitachi Chemical Diagnostics, Inc.
Decision Date2013-03-22
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Chemical Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-03-22 under 510(k) number K130141. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)?

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) is a medical device that received FDA 510(k) clearance on 2013-03-22. The listed applicant is Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K130141.

When did S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) receive FDA 510(k) clearance?

S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) received FDA 510(k) clearance on 2013-03-22, under 510(k) number K130141.

Who is the listed applicant for S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)?

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

What is the FDA product code for S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)?

The FDA product code for S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) is CJE.

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Other records listing Hitachi Chemical Diagnostics, Inc. as applicant

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Related Devices (Code: CJE)

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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