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FDA 510(k)

ETHYL ALCOHOL CALIBRATORS & CONTROL

K-Number: K924733 · 1992-12-09

ApplicantDiagnostic Reagents, Inc.
Decision Date1992-12-09
Product CodeDNN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHYL ALCOHOL CALIBRATORS & CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1992-12-09 under 510(k) number K924733. 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 CALIBRATORS & CONTROL?

ETHYL ALCOHOL CALIBRATORS & CONTROL is a medical device that received FDA 510(k) clearance on 1992-12-09. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K924733.

When did ETHYL ALCOHOL CALIBRATORS & CONTROL receive FDA 510(k) clearance?

ETHYL ALCOHOL CALIBRATORS & CONTROL received FDA 510(k) clearance on 1992-12-09, under 510(k) number K924733.

Who is the listed applicant for ETHYL ALCOHOL CALIBRATORS & CONTROL?

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

What is the FDA product code for ETHYL ALCOHOL CALIBRATORS & CONTROL?

The FDA product code for ETHYL ALCOHOL CALIBRATORS & CONTROL is DNN.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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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.K882117ETHYL ALCOHOL STANDARDVerichem Laboratories, 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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