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FDA 510(k)

AMES TDA THEOPHYLLINE TEST

K-Number: K812518 · 1981-09-23

ApplicantMiles Laboratories, Inc.
Decision Date1981-09-23
Product CodeLER
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA THEOPHYLLINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812518. 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 AMES TDA THEOPHYLLINE TEST?

AMES TDA THEOPHYLLINE TEST is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K812518.

When did AMES TDA THEOPHYLLINE TEST receive FDA 510(k) clearance?

AMES TDA THEOPHYLLINE TEST received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812518.

Who is the listed applicant for AMES TDA THEOPHYLLINE TEST?

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

What is the FDA product code for AMES TDA THEOPHYLLINE TEST?

The FDA product code for AMES TDA THEOPHYLLINE TEST is LER.

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Other records listing Miles 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.

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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 CompanyK842585THEOPHYLLINE KIT FLUORESCENCE POLARIZA-Windsor 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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