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FDA 510(k)

AMES TDA PHENOBARBITAL TEST

K-Number: K842592 · 1984-08-17

ApplicantMiles Laboratories, Inc.
Decision Date1984-08-17
Product CodeLET
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA PHENOBARBITAL 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 1984-08-17 under 510(k) number K842592. The device is classified under product code LET. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES TDA PHENOBARBITAL TEST?

AMES TDA PHENOBARBITAL TEST is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K842592.

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

AMES TDA PHENOBARBITAL TEST received FDA 510(k) clearance on 1984-08-17, under 510(k) number K842592.

Who is the listed applicant for AMES TDA PHENOBARBITAL 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 PHENOBARBITAL TEST?

The FDA product code for AMES TDA PHENOBARBITAL TEST is LET.

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Other records listing Miles Laboratories, Inc. as applicant

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Related Devices (Code: LET)

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.

K901537MODIFIED OPUS PHENOBARBITAL TEST SYSTEMPb Diagnostic Systems, Inc.K865000IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTSSclavo, Inc.K830701STRATUS PHENOBARBITAL FLUOROMETRIC ENZAmerican DadeK821408PHENOBARBITAL FLUORESCENT IMMUNOAmerican Diagnostic Corp.K820188PHENOBARBITAL ASSAYSyva Co.K810994AMES TDA TM PHENOBARBITAL 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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