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FDA 510(k)

THEOPHYLLINE KIT FLUORESCENCE POLARIZA-

K-Number: K842585 · 1984-09-26

ApplicantWindsor Laboratories, Inc.
Decision Date1984-09-26
Product CodeLER
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THEOPHYLLINE KIT FLUORESCENCE POLARIZA- 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 K842585. The device is classified under product code LER. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEOPHYLLINE KIT FLUORESCENCE POLARIZA-?

THEOPHYLLINE KIT FLUORESCENCE POLARIZA- 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 K842585.

When did THEOPHYLLINE KIT FLUORESCENCE POLARIZA- receive FDA 510(k) clearance?

THEOPHYLLINE KIT FLUORESCENCE POLARIZA- received FDA 510(k) clearance on 1984-09-26, under 510(k) number K842585.

Who is the listed applicant for THEOPHYLLINE KIT FLUORESCENCE POLARIZA-?

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 THEOPHYLLINE KIT FLUORESCENCE POLARIZA-?

The FDA product code for THEOPHYLLINE KIT FLUORESCENCE POLARIZA- is LER.

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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 BUFFERK870389DIGOXIN (FPIA) CALIBRATOR KITK870390PHENOBARBITAL (FPIA) CALIBRATOR KITK864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY

View all 19 devices →

Related Devices (Code: LER)

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.

K942192THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905521CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATIONMicrogenics Corp.K882570TURBOX THEOPHYLLINE ASSAYUnipath , Ltd.K864409IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTSSclavo, Inc.K863475THEOFAST(TM) TEST PACKAGE3M CompanyK840758IMMPULSE THEOPHYLLINE ASSAY REAGENTSParagon Diagnostics, 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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