FDA 510(k)

EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)

K-Number: K915003 · 1991-11-29

Decision Date1991-11-29

Product CodeDKB

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 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 1991-11-29 under 510(k) number K915003. 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 CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)?

EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Syva Co.. The 510(k) number is K915003.

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

EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) received FDA 510(k) clearance on 1991-11-29, under 510(k) number K915003.

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

The FDA product code for EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 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.