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FDA 510(k)

ACCULEVEL PHENYTOIN TEST

K-Number: K855026 · 1986-08-25

ApplicantSyva / A Syntex Co.
Decision Date1986-08-25
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCULEVEL PHENYTOIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syva / A Syntex Co.. It received FDA 510(k) clearance on 1986-08-25 under 510(k) number K855026. 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 ACCULEVEL PHENYTOIN TEST?

ACCULEVEL PHENYTOIN TEST is a medical device that received FDA 510(k) clearance on 1986-08-25. The listed applicant is Syva / A Syntex Co.. The 510(k) number is K855026.

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

ACCULEVEL PHENYTOIN TEST received FDA 510(k) clearance on 1986-08-25, under 510(k) number K855026.

Who is the listed applicant for ACCULEVEL PHENYTOIN TEST?

The FDA 510(k) record lists Syva / A Syntex Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCULEVEL PHENYTOIN TEST?

The FDA product code for ACCULEVEL PHENYTOIN TEST is DIP.

Related Clinical Trials

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.

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Other records listing Syva / A Syntex 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.

K861511EMIT CAFFEINE CONTROL

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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