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FDA 510(k)

URIC ACID SYSTEM PACK TEST

K-Number: K812978 · 1981-11-06

ApplicantBoehringer Mannheim Corp.
Decision Date1981-11-06
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID SYSTEM PACK TEST is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812978. 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 SYSTEM PACK TEST?

URIC ACID SYSTEM PACK TEST is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K812978.

When did URIC ACID SYSTEM PACK TEST receive FDA 510(k) clearance?

URIC ACID SYSTEM PACK TEST received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812978.

Who is the listed applicant for URIC ACID SYSTEM PACK TEST?

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

What is the FDA product code for URIC ACID SYSTEM PACK TEST?

The FDA product code for URIC ACID SYSTEM PACK TEST is KNK.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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