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FDA 510(k)

CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY

K-Number: K873282 · 1987-09-22

ApplicantWindsor Laboratories, Inc.
Decision Date1987-09-22
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY 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 1987-09-22 under 510(k) number K873282. 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 FPIA FLUORES. POLARIZA. IMMUNOASSAY?

CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1987-09-22. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K873282.

When did CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY receive FDA 510(k) clearance?

CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY received FDA 510(k) clearance on 1987-09-22, under 510(k) number K873282.

Who is the listed applicant for CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY?

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 FLUORES. POLARIZA. IMMUNOASSAY?

The FDA product code for CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY is KLT.

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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.

K873281CARBAMAZEPINE (FPIA) CALIBRATOR KITK871486(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: 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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