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FDA 510(k)

ACCULEVEL PHENOBARBITAL TEST

K-Number: K854607 · 1986-08-25

ApplicantSyva Co.
Decision Date1986-08-25
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCULEVEL PHENOBARBITAL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1986-08-25 under 510(k) number K854607. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCULEVEL PHENOBARBITAL TEST?

ACCULEVEL PHENOBARBITAL TEST is a medical device that received FDA 510(k) clearance on 1986-08-25. The listed applicant is Syva Co.. The 510(k) number is K854607.

When did ACCULEVEL PHENOBARBITAL TEST receive FDA 510(k) clearance?

ACCULEVEL PHENOBARBITAL TEST received FDA 510(k) clearance on 1986-08-25, under 510(k) number K854607.

Who is the listed applicant for ACCULEVEL PHENOBARBITAL TEST?

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 ACCULEVEL PHENOBARBITAL TEST?

The FDA product code for ACCULEVEL PHENOBARBITAL TEST is DLZ.

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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: DLZ)

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.

K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.K123271ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott LaboratoriesK071644ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.K011303RANDOX PHENOBARBITALRandox Laboratories, Ltd.K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.

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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