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FDA 510(k)

EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS

K-Number: K913066 · 1991-07-30

ApplicantSyva Co.
Decision Date1991-07-30
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1991-07-30 under 510(k) number K913066. 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(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS?

EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is Syva Co.. The 510(k) number is K913066.

When did EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS receive FDA 510(k) clearance?

EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS received FDA 510(k) clearance on 1991-07-30, under 510(k) number K913066.

Who is the listed applicant for EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS?

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

What is the FDA product code for EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS?

The FDA product code for EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS is KLT.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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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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