Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRIMIDONE (FPIA) KIT

K-Number: K895567 · 1989-10-20

ApplicantTudor Laboratories, Inc.
Decision Date1989-10-20
Product CodeLFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PRIMIDONE (FPIA) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Tudor Laboratories, Inc.. It received FDA 510(k) clearance on 1989-10-20 under 510(k) number K895567. The device is classified under product code LFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMIDONE (FPIA) KIT?

PRIMIDONE (FPIA) KIT is a medical device that received FDA 510(k) clearance on 1989-10-20. The listed applicant is Tudor Laboratories, Inc.. The 510(k) number is K895567.

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

PRIMIDONE (FPIA) KIT received FDA 510(k) clearance on 1989-10-20, under 510(k) number K895567.

Who is the listed applicant for PRIMIDONE (FPIA) KIT?

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

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

The FDA product code for PRIMIDONE (FPIA) KIT is LFT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tudor 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.

K921904THYROXINE (FPIA) KITK921903THYROXINE CALIBRATOR KITK913240DIGITOXIN (FPIA) KITK895572N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KITK895571N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KITK895569VALPROIC ACID (FPIA) KIT

View all 9 devices →

Related Devices (Code: LFT)

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.

K950028PRIMIDONE FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K904683STRATUS PRIMIDONE FLUOROMETRIC ENZYMEBaxter Healthcare CorpK852318COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORSRoche Diagnostic Systems, Inc.K842196STRATUS PRIMIDONE FLOROMETRIC ENZYAmerican DadeK823741ADVANCE EMIT-AED PRIMEDONE ASSAYSyva Co.K822229PRIMIDONE FLUORESCENT IMMUNOASSAYAmerican Diagnostic Corp.

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.

↑