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FDA 510(k)

URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C

K-Number: K880584 · 1988-05-31

ApplicantMach Diag. C/O Wichita State University
Decision Date1988-05-31
Product CodeCDM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C is the device name listed in this FDA 510(k) record. The listed applicant is Mach Diag. C/O Wichita State University. It received FDA 510(k) clearance on 1988-05-31 under 510(k) number K880584. The device is classified under product code CDM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C?

URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Mach Diag. C/O Wichita State University. The 510(k) number is K880584.

When did URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C receive FDA 510(k) clearance?

URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C received FDA 510(k) clearance on 1988-05-31, under 510(k) number K880584.

Who is the listed applicant for URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C?

The FDA 510(k) record lists Mach Diag. C/O Wichita State University as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C?

The FDA product code for URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C is CDM.

Other records listing Mach Diag. C/O Wichita State University 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.

K880585DEXPAD, BLOOD GLUCOSE STRIP

Related Devices (Code: CDM)

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.

K052719URITEST 10 URINALYSIS REAGENT STRIPSArj Medical, Inc.K061559ACON URINALYSIS REAGENT STRIPSAcon Laboratories Co.K873366WAKO(TM) PRETEST 5AWako Chemicals USA, Inc.K852611TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINEMiles Laboratories, Inc.K830340FITKIT I CHECKUP KITBoditestorK821799FITKIT I CHECKUP KITPatton, Boggs & Blow

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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