FDA 510(k)

EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)

K-Number: K904764 · 1990-11-20

Decision Date1990-11-20

Product CodeDKB

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K904764. 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 A LEVEL 1 (CUTOFF) 2 (HIGH)?

EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Syva Co.. The 510(k) number is K904764.

When did EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) receive FDA 510(k) clearance?

EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) received FDA 510(k) clearance on 1990-11-20, under 510(k) number K904764.

Who is the listed applicant for EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)?

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 A LEVEL 1 (CUTOFF) 2 (HIGH)?

The FDA product code for EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) is DKB.

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Other records listing Syva Co. as applicant

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL K012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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Related Devices (Code: DKB)

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics Corporation K092266RANDOX 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 Diagnostics K090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare Diagnostics K062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)Dade Behring, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.