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FDA 510(k)

EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95

K-Number: K862403 · 1986-07-11

ApplicantDiagnostic Systems
Decision Date1986-07-11
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K862403. The device is classified under product code DKB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95?

EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Diagnostic Systems. The 510(k) number is K862403.

When did EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 receive FDA 510(k) clearance?

EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 received FDA 510(k) clearance on 1986-07-11, under 510(k) number K862403.

Who is the listed applicant for EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95?

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

What is the FDA product code for EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95?

The FDA product code for EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 is DKB.

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Other records listing Diagnostic Systems 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.

K905146OLYMPUS URINE PHK893691EMDS CREATINE KINASE ITEM NIMBER 65411K893692EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405K893966HDL PRECIPITATING REAGENTK884993VISUAL BLOOD GLUCOSE TEST SYSTEMK881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641

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Related Devices (Code: DKB)

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.

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics CorporationK092266RANDOX METHAMPHETAMINE ASSAYRandox Laboratories, Ltd.K101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSMicrogenics Corp.K090939ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190Roche DiagnosticsK090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare DiagnosticsK062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)Dade Behring, 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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