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 REAGENT SET AND CALIBRATORS

K-Number: K950028 · 1995-03-21

ApplicantSigma Diagnostics, Inc.
Decision Date1995-03-21
Product CodeLFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PRIMIDONE FPIA REAGENT SET AND CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-03-21 under 510(k) number K950028. 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 REAGENT SET AND CALIBRATORS?

PRIMIDONE FPIA REAGENT SET AND CALIBRATORS is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K950028.

When did PRIMIDONE FPIA REAGENT SET AND CALIBRATORS receive FDA 510(k) clearance?

PRIMIDONE FPIA REAGENT SET AND CALIBRATORS received FDA 510(k) clearance on 1995-03-21, under 510(k) number K950028.

Who is the listed applicant for PRIMIDONE FPIA REAGENT SET AND CALIBRATORS?

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

What is the FDA product code for PRIMIDONE FPIA REAGENT SET AND CALIBRATORS?

The FDA product code for PRIMIDONE FPIA REAGENT SET AND CALIBRATORS 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 Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

View all 164 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.

K904683STRATUS PRIMIDONE FLUOROMETRIC ENZYMEBaxter Healthcare CorpK895567PRIMIDONE (FPIA) KITTudor Laboratories, Inc.K852318COBAS 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.

↑