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FDA 510(k)

ETHYL ALCOHOL STANDARD

K-Number: K882117 · 1988-08-04

ApplicantVerichem Laboratories, Inc.
Decision Date1988-08-04
Product CodeDNN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHYL ALCOHOL STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Verichem Laboratories, Inc.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K882117. The device is classified under product code DNN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHYL ALCOHOL STANDARD?

ETHYL ALCOHOL STANDARD is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Verichem Laboratories, Inc.. The 510(k) number is K882117.

When did ETHYL ALCOHOL STANDARD receive FDA 510(k) clearance?

ETHYL ALCOHOL STANDARD received FDA 510(k) clearance on 1988-08-04, under 510(k) number K882117.

Who is the listed applicant for ETHYL ALCOHOL STANDARD?

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

What is the FDA product code for ETHYL ALCOHOL STANDARD?

The FDA product code for ETHYL ALCOHOL STANDARD is DNN.

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Other records listing Verichem Laboratories, 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.

K112834MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLESK974290MICROPROTEIN STANDARD KITK973345MATRIX PLUS MULTI-CALIBRATOR KITK972333AMMONIA/IRON STANDARD KITK924904HDL-CHOLESTEROL STANDARD, MODIFICATIONK912513ELECTROLYTE CONTROL

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Related Devices (Code: DNN)

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.

K990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc.K973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc.K924733ETHYL ALCOHOL CALIBRATORS & CONTROLDiagnostic Reagents, Inc.K853532ALCOHOL CALIBRATORSDiagnostic SystemsK810466ETHYL ALCOHOL SERUM CALIBRATORSyva Co.K802620EMIT-STM ETHYL ALCOHOL URINE CALIBRATORSyva Co.

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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