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FDA 510(k)

ADVIA IMS CARBAMAZEPINE METHOD

K-Number: K042808 · 2005-02-08

ApplicantBayer Healthcare, LLC
Decision Date2005-02-08
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ADVIA IMS CARBAMAZEPINE METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2005-02-08 under 510(k) number K042808. 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 ADVIA IMS CARBAMAZEPINE METHOD?

ADVIA IMS CARBAMAZEPINE METHOD is a medical device that received FDA 510(k) clearance on 2005-02-08. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K042808.

When did ADVIA IMS CARBAMAZEPINE METHOD receive FDA 510(k) clearance?

ADVIA IMS CARBAMAZEPINE METHOD received FDA 510(k) clearance on 2005-02-08, under 510(k) number K042808.

Who is the listed applicant for ADVIA IMS CARBAMAZEPINE METHOD?

The FDA 510(k) record lists Bayer Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA IMS CARBAMAZEPINE METHOD?

The FDA product code for ADVIA IMS CARBAMAZEPINE METHOD is KLT.

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Other records listing Bayer Healthcare, LLC 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.

K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)K121190CONTOUR NEXT BLOOD GLUCOSE METERK110587CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)K093930DIDGET WORLD REPORTSK090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

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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 OYK031902ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.K011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.K010814EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229Syva Co., Dade Behring, 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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