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FDA 510(k)

IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00

K-Number: K942687 · 1995-01-25

ApplicantInstrumentation Laboratory CO
Decision Date1995-01-25
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1995-01-25 under 510(k) number K942687. 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 IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00?

IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00 is a medical device that received FDA 510(k) clearance on 1995-01-25. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K942687.

When did IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00 receive FDA 510(k) clearance?

IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00 received FDA 510(k) clearance on 1995-01-25, under 510(k) number K942687.

Who is the listed applicant for IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00?

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

What is the FDA product code for IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00?

The FDA product code for IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00 is KLT.

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Other records listing Instrumentation Laboratory CO as applicant

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K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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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