FDA 510(k)

PHENYTOIN KIT FLUORESCENCE POLARIZATION

K-Number: K842586 · 1984-09-26

Decision Date1984-09-26

Product CodeLGR

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

PHENYTOIN KIT FLUORESCENCE POLARIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Laboratories, Inc.. It received FDA 510(k) clearance on 1984-09-26 under 510(k) number K842586. The device is classified under product code LGR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHENYTOIN KIT FLUORESCENCE POLARIZATION?

PHENYTOIN KIT FLUORESCENCE POLARIZATION is a medical device that received FDA 510(k) clearance on 1984-09-26. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K842586.

When did PHENYTOIN KIT FLUORESCENCE POLARIZATION receive FDA 510(k) clearance?

PHENYTOIN KIT FLUORESCENCE POLARIZATION received FDA 510(k) clearance on 1984-09-26, under 510(k) number K842586.

Who is the listed applicant for PHENYTOIN KIT FLUORESCENCE POLARIZATION?

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

What is the FDA product code for PHENYTOIN KIT FLUORESCENCE POLARIZATION?

The FDA product code for PHENYTOIN KIT FLUORESCENCE POLARIZATION is LGR.

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Other records listing Windsor Laboratories, Inc. as applicant

K873281CARBAMAZEPINE (FPIA) CALIBRATOR KIT K873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY K871486(FPIA) ASSAY BUFFER K870389DIGOXIN (FPIA) CALIBRATOR KIT K870390PHENOBARBITAL (FPIA) CALIBRATOR KIT K864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY

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Related Devices (Code: LGR)

K955873ACS PHENYTOIN ASSAYCiba Corning Diagnostics Corp.K955562INNOFLUOR PHENYTOIN ASSAY SYSTEMOxis Intl., Inc.K953840AXSYM PHENYTOIN IIAbbott Laboratories K946328TDX(R)/TDXFLX(R) PHENYTOIN IIAbbott Laboratories K943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K935375AXSYM PHENYTOIN ASSAYAbbott Laboratories

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.