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FDA 510(k)

EMIT CONVENIENCE PACK: PHENYTOIN ASSAY

K-Number: K874856 · 1988-01-05

ApplicantSyva Co.
Decision Date1988-01-05
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT CONVENIENCE PACK: PHENYTOIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1988-01-05 under 510(k) number K874856. The device is classified under product code DIP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT CONVENIENCE PACK: PHENYTOIN ASSAY?

EMIT CONVENIENCE PACK: PHENYTOIN ASSAY is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Syva Co.. The 510(k) number is K874856.

When did EMIT CONVENIENCE PACK: PHENYTOIN ASSAY receive FDA 510(k) clearance?

EMIT CONVENIENCE PACK: PHENYTOIN ASSAY received FDA 510(k) clearance on 1988-01-05, under 510(k) number K874856.

Who is the listed applicant for EMIT CONVENIENCE PACK: PHENYTOIN ASSAY?

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 CONVENIENCE PACK: PHENYTOIN ASSAY?

The FDA product code for EMIT CONVENIENCE PACK: PHENYTOIN ASSAY is DIP.

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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: DIP)

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.

K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01Abbott LaboratoriesK063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSThermo Electron OYK030428ROCHE ONLINE TDM PHENYTOINRoche Diagnostics Corp.K011393RANDOX PHENYTOINRandox Laboratories, Ltd.K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229Syva Co.K000006IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6Diagnostic Products Corp.

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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