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FDA 510(k)

EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229

K-Number: K010814 · 2001-04-13

ApplicantSyva Co., Dade Behring, Inc.
Decision Date2001-04-13
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co., Dade Behring, Inc.. It received FDA 510(k) clearance on 2001-04-13 under 510(k) number K010814. 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 EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229?

EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 is a medical device that received FDA 510(k) clearance on 2001-04-13. The listed applicant is Syva Co., Dade Behring, Inc.. The 510(k) number is K010814.

When did EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 receive FDA 510(k) clearance?

EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 received FDA 510(k) clearance on 2001-04-13, under 510(k) number K010814.

Who is the listed applicant for EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229?

The FDA 510(k) record lists Syva Co., Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229?

The FDA product code for EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 is KLT.

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Other records listing Syva Co., Dade Behring, 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.

K011920EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229K011300EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229K011306EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229K011161MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

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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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