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FDA 510(k)

EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR

K-Number: K890452 · 1989-02-10

ApplicantSyva Co.
Decision Date1989-02-10
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1989-02-10 under 510(k) number K890452. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR?

EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR is a medical device that received FDA 510(k) clearance on 1989-02-10. The listed applicant is Syva Co.. The 510(k) number is K890452.

When did EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR receive FDA 510(k) clearance?

EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR received FDA 510(k) clearance on 1989-02-10, under 510(k) number K890452.

Who is the listed applicant for EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR?

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) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR?

The FDA product code for EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR is DLJ.

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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: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)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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