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FDA 510(k)

AMES TDA TM PHENYTOIN TEST

K-Number: K811025 · 1981-04-29

ApplicantMiles Laboratories, Inc.
Decision Date1981-04-29
Product CodeLES
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA TM PHENYTOIN 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 1981-04-29 under 510(k) number K811025. The device is classified under product code LES. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES TDA TM PHENYTOIN TEST?

AMES TDA TM PHENYTOIN TEST is a medical device that received FDA 510(k) clearance on 1981-04-29. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K811025.

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

AMES TDA TM PHENYTOIN TEST received FDA 510(k) clearance on 1981-04-29, under 510(k) number K811025.

Who is the listed applicant for AMES TDA TM PHENYTOIN 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 TM PHENYTOIN TEST?

The FDA product code for AMES TDA TM PHENYTOIN TEST is LES.

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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: LES)

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.

K865102IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTSSclavo, Inc.K844990SYVA ADVANCE EMIT PHENYTOIN ASSAYSyva Co.K831154STRATUS PHENYTOIN FLUOROMETRIC ENZYMEAmerican DadeK820187SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENYSyva Co.K813538PHENYTOIN FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.K801736AMES TDA TM PHENYTOIN TESTMiles 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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