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FDA 510(k)

URIC ACID REAGENT (PRODUCT #88219)

K-Number: K883404 · 1988-09-13

ApplicantHichem Diagnostics
Decision Date1988-09-13
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID REAGENT (PRODUCT #88219) is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1988-09-13 under 510(k) number K883404. The device is classified under product code KNK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIC ACID REAGENT (PRODUCT #88219)?

URIC ACID REAGENT (PRODUCT #88219) is a medical device that received FDA 510(k) clearance on 1988-09-13. The listed applicant is Hichem Diagnostics. The 510(k) number is K883404.

When did URIC ACID REAGENT (PRODUCT #88219) receive FDA 510(k) clearance?

URIC ACID REAGENT (PRODUCT #88219) received FDA 510(k) clearance on 1988-09-13, under 510(k) number K883404.

Who is the listed applicant for URIC ACID REAGENT (PRODUCT #88219)?

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

What is the FDA product code for URIC ACID REAGENT (PRODUCT #88219)?

The FDA product code for URIC ACID REAGENT (PRODUCT #88219) is KNK.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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Related Devices (Code: KNK)

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.

K102568URIC ACID MODEL 3P39Abbott LaboratoriesK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc.K040467VITALAB URIC ACID REAGENTClinical Data, Inc.K031044ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORClinical Data, Inc.K022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAWiener Laboratories Saic

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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