Modified Accufluor Carbamazepine Reagent & Calibra

FDA 510(k) K900702 · Innotron of Oregon, Inc.

Substantially Equivalent

510(k) numberK900702

Submission

Device name
Modified Accufluor Carbamazepine Reagent & Calibra
Applicant
Innotron of Oregon, Inc.
Portland, OR, US
Received
February 12, 1990
Decision date
April 12, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LGI – Fluorescence Polarization Immunoassay, Carbamazepine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3645
Specialty
Clinical Toxicology

Other 510(k)s with product code LGI

510(k)DeviceApplicantDecision
K944063Fluorescence Polarization Immunoassay CarbamazepineLGI · Traditional Sigma Diagnostics, Inc.11/10/1994SE
K940682Axsym(Tm) QuinidineLGI · Traditional Abbott Laboratories06/21/1994SE

More from Abbott Laboratories

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K903101Innofluor (TM) Amikacin Calibrator SetDLJ · Traditional 08/22/1990SE
K903100Innofluor (TM) Amikacin Reagent SetKLQ · Traditional 08/09/1990SE
K900707Modified Accufluor Tobramycin Reagent & CalibratorLFW · Traditional 04/20/1990SE
K900708Modified Accufluor Vancomycin Reagent & CalibratorLEH · Traditional 04/19/1990SE
K900706Modified Accufluor Theophylline Reagent & CalibraLGS · Traditional 04/12/1990SE
K900705Modified Accufluor Quinidine Reagent & CalibratorLBZ · Traditional 04/12/1990SE
K900704Modified Accufluor Phenobarbital Reagent & CalibraLGQ · Traditional 04/12/1990SE
K900703Modified Accufluor Gentamicin Reagent & CalibratorLCD · Traditional 04/12/1990SE
K895827Innofluor Phenytoin Manual Fpia Reagent SetLGR · Traditional 10/31/1989SE
K895828Innofluor Digoxin Reagent SetLCS · Traditional 10/30/1989SE

Questions and answers

When was Modified Accufluor Carbamazepine Reagent & Calibra cleared by the FDA?

Modified Accufluor Carbamazepine Reagent & Calibra (K900702) received a 510(k) decision of Substantially Equivalent on April 12, 1990, 59 days after the submission was received.

What is the product code of K900702?

The FDA product code is LGI – Fluorescence Polarization Immunoassay, Carbamazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3645.