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FDA 510(k)

PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT

K-Number: K863625 · 1986-11-10

ApplicantWindsor Laboratories, Inc.
Decision Date1986-11-10
Product CodeLGQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT 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 1986-11-10 under 510(k) number K863625. The device is classified under product code LGQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT?

PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1986-11-10. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K863625.

When did PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT receive FDA 510(k) clearance?

PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT received FDA 510(k) clearance on 1986-11-10, under 510(k) number K863625.

Who is the listed applicant for PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT?

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 PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT?

The FDA product code for PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT is LGQ.

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 Windsor Laboratories, Inc. 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.

K873281CARBAMAZEPINE (FPIA) CALIBRATOR KITK873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYK871486(FPIA) ASSAY BUFFERK870390PHENOBARBITAL (FPIA) CALIBRATOR KITK870389DIGOXIN (FPIA) CALIBRATOR KITK864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY

View all 19 devices →

Related Devices (Code: LGQ)

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.

K972331INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K972330INNOFLUOR PHENOBARBITAL ASSAY SYSTEMOxis Intl., Inc.K940596AXSYM PHENOBARBITALAbbott LaboratoriesK936130COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORSRoche Diagnostic Systems, Inc.K900704MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRAInnotron of Oregon, Inc.K894525FPR PHENOBARBITAL KITColony Laboratories, Inc.

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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