FDA 510(k)

GEMENI URIC ACID U.V.

K-Number: K873358 · 1987-09-11

ApplicantElectro-Nucleonics Laboratories, Inc.

Decision Date1987-09-11

Product CodeCDO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GEMENI URIC ACID U.V. is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1987-09-11 under 510(k) number K873358. 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 GEMENI URIC ACID U.V.?

GEMENI URIC ACID U.V. is a medical device that received FDA 510(k) clearance on 1987-09-11. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K873358.

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

GEMENI URIC ACID U.V. received FDA 510(k) clearance on 1987-09-11, under 510(k) number K873358.

Who is the listed applicant for GEMENI URIC ACID U.V.?

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

What is the FDA product code for GEMENI URIC ACID U.V.?

The FDA product code for GEMENI URIC ACID U.V. is CDO.

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Other records listing Electro-Nucleonics Laboratories, Inc. as applicant

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Related Devices (Code: CDO)

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 Laboratories K981189URIC ACIDAbbott Laboratories K971485URIC 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.