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FDA 510(k)

ACE CEDIA PHENOBARBITAL ASSAY

K-Number: K942501 · 1994-10-06

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1994-10-06
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACE CEDIA PHENOBARBITAL ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Schiapparelli Biosystems, Inc.. It received FDA 510(k) clearance on 1994-10-06 under 510(k) number K942501. 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 ACE CEDIA PHENOBARBITAL ASSAY?

ACE CEDIA PHENOBARBITAL ASSAY is a medical device that received FDA 510(k) clearance on 1994-10-06. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K942501.

When did ACE CEDIA PHENOBARBITAL ASSAY receive FDA 510(k) clearance?

ACE CEDIA PHENOBARBITAL ASSAY received FDA 510(k) clearance on 1994-10-06, under 510(k) number K942501.

Who is the listed applicant for ACE CEDIA PHENOBARBITAL ASSAY?

The FDA 510(k) record lists Schiapparelli Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE CEDIA PHENOBARBITAL ASSAY?

The FDA product code for ACE CEDIA PHENOBARBITAL ASSAY is DLZ.

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Other records listing Schiapparelli Biosystems, Inc. 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.

K991733ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLSK981377ACE T4 REAGENT T4 CALIBRATORSK981375ACE T UPTAKE REAGENT TU CALIBRATORSK973581ACE VALPROIC ACID REAGENT, AED CALIBRATORSK973583ACE THEOPHYLLINE REAGENT, THEO CALIBRATORSK973582ACE PRIMIDONE REAGENT, AED CALIBRATORS

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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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