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FDA 510(k)

IL TEST PHENYTOIN

K-Number: K860286 · 1986-03-05

ApplicantAllied Instrumentation Laboratory
Decision Date1986-03-05
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IL TEST PHENYTOIN is the device name listed in this FDA 510(k) record. The listed applicant is Allied Instrumentation Laboratory. It received FDA 510(k) clearance on 1986-03-05 under 510(k) number K860286. 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 IL TEST PHENYTOIN?

IL TEST PHENYTOIN is a medical device that received FDA 510(k) clearance on 1986-03-05. The listed applicant is Allied Instrumentation Laboratory. The 510(k) number is K860286.

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

IL TEST PHENYTOIN received FDA 510(k) clearance on 1986-03-05, under 510(k) number K860286.

Who is the listed applicant for IL TEST PHENYTOIN?

The FDA 510(k) record lists Allied Instrumentation Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IL TEST PHENYTOIN?

The FDA product code for IL TEST PHENYTOIN is DIP.

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Other records listing Allied Instrumentation Laboratory 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.

K861901MULTI-4 CO-OXIMETER CONTROLK860365PHENOBARBITAL TEST SYSTEMK853858IL TEST THEOPHYLLINE ASSAYK852676IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERSK851933CLINICAL CHEMISTRY ANALYTICAL SYSTEMK850748I-L TEST, DIRECT BILIRUBIN SET

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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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