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FDA 510(k)

CARBAMAZEPINE EIA TEST

K-Number: K955100 · 1995-12-13

ApplicantDiagnostic Reagents, Inc.
Decision Date1995-12-13
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CARBAMAZEPINE EIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1995-12-13 under 510(k) number K955100. 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 CARBAMAZEPINE EIA TEST?

CARBAMAZEPINE EIA TEST is a medical device that received FDA 510(k) clearance on 1995-12-13. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K955100.

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

CARBAMAZEPINE EIA TEST received FDA 510(k) clearance on 1995-12-13, under 510(k) number K955100.

Who is the listed applicant for CARBAMAZEPINE EIA TEST?

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

What is the FDA product code for CARBAMAZEPINE EIA TEST?

The FDA product code for CARBAMAZEPINE EIA TEST is KLT.

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Other records listing Diagnostic Reagents, 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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSK973102LIDOCAINE EIA ASSAY

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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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