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FDA 510(k)

CARBAMAZEPINE (FPIA) CALIBRATOR KIT

K-Number: K873281 · 1987-10-28

ApplicantWindsor Laboratories, Inc.
Decision Date1987-10-28
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CARBAMAZEPINE (FPIA) CALIBRATOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Laboratories, Inc.. It received FDA 510(k) clearance on 1987-10-28 under 510(k) number K873281. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBAMAZEPINE (FPIA) CALIBRATOR KIT?

CARBAMAZEPINE (FPIA) CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 1987-10-28. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K873281.

When did CARBAMAZEPINE (FPIA) CALIBRATOR KIT receive FDA 510(k) clearance?

CARBAMAZEPINE (FPIA) CALIBRATOR KIT received FDA 510(k) clearance on 1987-10-28, under 510(k) number K873281.

Who is the listed applicant for CARBAMAZEPINE (FPIA) CALIBRATOR KIT?

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

What is the FDA product code for CARBAMAZEPINE (FPIA) CALIBRATOR KIT?

The FDA product code for CARBAMAZEPINE (FPIA) CALIBRATOR KIT is DLJ.

Related Clinical Trials

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.

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Other records listing Windsor Laboratories, 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.

K873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYK871486(FPIA) ASSAY BUFFERK870390PHENOBARBITAL (FPIA) CALIBRATOR KITK870389DIGOXIN (FPIA) CALIBRATOR KITK864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAYK863625PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT

View all 19 devices →

Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, Inc.

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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