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FDA 510(k)

IL TEST PHENYTION CALIBRATORS

K-Number: K943980 · 1995-05-01

ApplicantInstrumentation Laboratory CO
Decision Date1995-05-01
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IL TEST PHENYTION CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1995-05-01 under 510(k) number K943980. 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 PHENYTION CALIBRATORS?

IL TEST PHENYTION CALIBRATORS is a medical device that received FDA 510(k) clearance on 1995-05-01. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K943980.

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

IL TEST PHENYTION CALIBRATORS received FDA 510(k) clearance on 1995-05-01, under 510(k) number K943980.

Who is the listed applicant for IL TEST PHENYTION CALIBRATORS?

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

What is the FDA product code for IL TEST PHENYTION CALIBRATORS?

The FDA product code for IL TEST PHENYTION CALIBRATORS is DIP.

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Other records listing Instrumentation Laboratory 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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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