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FDA 510(k)

CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

K-Number: K964068 · 1996-12-13

ApplicantBayer Corp.
Decision Date1996-12-13
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1996-12-13 under 510(k) number K964068. 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 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM?

CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-13. The listed applicant is Bayer Corp.. The 510(k) number is K964068.

When did CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM receive FDA 510(k) clearance?

CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM received FDA 510(k) clearance on 1996-12-13, under 510(k) number K964068.

Who is the listed applicant for CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM?

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

What is the FDA product code for CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM?

The FDA product code for CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM is KLT.

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Other records listing Bayer Corp. 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

View all 96 devices →

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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