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FDA 510(k)

CARBAMAZEPINE FLEX REAGENT CARTRIDGE

K-Number: K962820 · 1996-09-13

ApplicantDade Intl., Inc.
Decision Date1996-09-13
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CARBAMAZEPINE FLEX REAGENT CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1996-09-13 under 510(k) number K962820. 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 FLEX REAGENT CARTRIDGE?

CARBAMAZEPINE FLEX REAGENT CARTRIDGE is a medical device that received FDA 510(k) clearance on 1996-09-13. The listed applicant is Dade Intl., Inc.. The 510(k) number is K962820.

When did CARBAMAZEPINE FLEX REAGENT CARTRIDGE receive FDA 510(k) clearance?

CARBAMAZEPINE FLEX REAGENT CARTRIDGE received FDA 510(k) clearance on 1996-09-13, under 510(k) number K962820.

Who is the listed applicant for CARBAMAZEPINE FLEX REAGENT CARTRIDGE?

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

What is the FDA product code for CARBAMAZEPINE FLEX REAGENT CARTRIDGE?

The FDA product code for CARBAMAZEPINE FLEX REAGENT CARTRIDGE is KLT.

Related Clinical Trials

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Other records listing Dade Intl., 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.

K974343DADE INNOVINK970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/K973974DADE TRU-LIQUID CARDIAC CONTROLK973668CARDIAC TROPONIN-I (TROP) CALIBRATORK972524DRIED GRAM-POSITIVE MIC/COMBO PANELSK972782DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

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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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