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FDA 510(k)

SPOTCHEM II LDH TEST

K-Number: K050790 · 2005-06-06

ApplicantArkray, Inc.
Decision Date2005-06-06
Product CodeCFH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPOTCHEM II LDH TEST is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2005-06-06 under 510(k) number K050790. The device is classified under product code CFH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOTCHEM II LDH TEST?

SPOTCHEM II LDH TEST is a medical device that received FDA 510(k) clearance on 2005-06-06. The listed applicant is Arkray, Inc.. The 510(k) number is K050790.

When did SPOTCHEM II LDH TEST receive FDA 510(k) clearance?

SPOTCHEM II LDH TEST received FDA 510(k) clearance on 2005-06-06, under 510(k) number K050790.

Who is the listed applicant for SPOTCHEM II LDH TEST?

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

What is the FDA product code for SPOTCHEM II LDH TEST?

The FDA product code for SPOTCHEM II LDH TEST is CFH.

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Related Devices (Code: CFH)

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.

K020484CARESIDE LDHCareside, Inc.K895138CLINISTAT LDH REAGENT TESTHeraeus Kulzer, Inc.K894578IQ LDHBd Becton Dickinson Vacutainer Systems PreanalyticK880630LACTATE DEHYDROGENASE (LDH-L)Tech-Co, Inc.K860349LACTATE DEHYDROGENASE (LDH) REAGENT SETSterling Diagnostics, Inc.K852391EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDUREHelena Laboratories

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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