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FDA 510(k)

AMES TDA CARBAMAZEPINE TEST

K-Number: K811952 · 1981-07-15

ApplicantMiles Laboratories, Inc.
Decision Date1981-07-15
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMES TDA CARBAMAZEPINE 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 1981-07-15 under 510(k) number K811952. The device is classified under product code KLT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES TDA CARBAMAZEPINE TEST?

AMES TDA CARBAMAZEPINE TEST is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K811952.

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

AMES TDA CARBAMAZEPINE TEST received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811952.

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

The FDA product code for AMES TDA CARBAMAZEPINE TEST is KLT.

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Other records listing Miles Laboratories, Inc. as applicant

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Related Devices (Code: KLT)

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.

K123518ABBOTT CARBAMAZEPINE ASSAYMicrogenics CorporationK103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSAbbott LaboratoriesK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSThermo Electron OYK042808ADVIA IMS CARBAMAZEPINE METHODBayer Healthcare, LLCK031902ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.K011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.

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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