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FDA 510(k)

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS

K-Number: K973054 · 1997-10-01

ApplicantEmd Chemicals, Inc.
Decision Date1997-10-01
Product CodeDNN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1997-10-01 under 510(k) number K973054. 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 CLINICAL STANDARD SOLUTIONS?

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K973054.

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

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS received FDA 510(k) clearance on 1997-10-01, under 510(k) number K973054.

Who is the listed applicant for ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS?

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

What is the FDA product code for ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS?

The FDA product code for ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS is DNN.

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Other records listing Emd Chemicals, 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.

K031367DUOPATH VEROTOXINS GLISA TESTK990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)K951750GLUCOSE TEST ITEM NUMBER 97375/94K950234TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2

View all 62 devices →

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.K924733ETHYL ALCOHOL CALIBRATORS & CONTROLDiagnostic Reagents, 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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