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FDA 510(k)

FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE

K-Number: K944063 · 1994-11-10

ApplicantSigma Diagnostics, Inc.
Decision Date1994-11-10
Product CodeLGI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-11-10 under 510(k) number K944063. The device is classified under product code LGI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE?

FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K944063.

When did FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE receive FDA 510(k) clearance?

FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE received FDA 510(k) clearance on 1994-11-10, under 510(k) number K944063.

Who is the listed applicant for FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE?

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

What is the FDA product code for FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE?

The FDA product code for FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE is LGI.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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Related Devices (Code: LGI)

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.

K940682AXSYM(TM) QUINIDINEAbbott LaboratoriesK900702MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRAInnotron of Oregon, 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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