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FDA 510(k)

EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)

K-Number: K902581 · 1990-07-27

ApplicantSyva Co.
Decision Date1990-07-27
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1990-07-27 under 510(k) number K902581. 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 EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)?

EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) is a medical device that received FDA 510(k) clearance on 1990-07-27. The listed applicant is Syva Co.. The 510(k) number is K902581.

When did EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) receive FDA 510(k) clearance?

EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) received FDA 510(k) clearance on 1990-07-27, under 510(k) number K902581.

Who is the listed applicant for EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)?

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

What is the FDA product code for EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)?

The FDA product code for EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) is DKB.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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