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FDA 510(k)

URICASE (U.V.) URIC ACID

K-Number: K821167 · 1982-05-14

ApplicantSyn-Kit, Inc.
Decision Date1982-05-14
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URICASE (U.V.) URIC ACID is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1982-05-14 under 510(k) number K821167. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URICASE (U.V.) URIC ACID?

URICASE (U.V.) URIC ACID is a medical device that received FDA 510(k) clearance on 1982-05-14. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K821167.

When did URICASE (U.V.) URIC ACID receive FDA 510(k) clearance?

URICASE (U.V.) URIC ACID received FDA 510(k) clearance on 1982-05-14, under 510(k) number K821167.

Who is the listed applicant for URICASE (U.V.) URIC ACID?

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

What is the FDA product code for URICASE (U.V.) URIC ACID?

The FDA product code for URICASE (U.V.) URIC ACID is CDO.

Related Clinical Trials

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Other records listing Syn-Kit, Inc. 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GK

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Related Devices (Code: CDO)

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.

K033278RANDOX URIC ACIDRandox Laboratories, Ltd.K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.

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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