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)

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA

K-Number: K980249 · 1998-03-13

ApplicantPrinceton BioMeditech Corp.
Decision Date1998-03-13
Product CodeLFG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K980249. The device is classified under product code LFG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA?

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K980249.

When did ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA receive FDA 510(k) clearance?

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA received FDA 510(k) clearance on 1998-03-13, under 510(k) number K980249.

Who is the listed applicant for ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA?

The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA?

The FDA product code for ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA is LFG.

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 Princeton BioMeditech Corp. 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.

K251538Status™ COVID-19/Flu A&BK182157BioSign Flu A+BK133474BIOSIGN FLU A + B, STATUS FLU A & BK132465BIOSIGN FLU A + B, STATUS FLU A & BK083746BIOSIGN FLU A+BK100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

View all 71 devices →

Related Devices (Code: LFG)

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.

K112395WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TESTGuangzhou Wondfo Biotech Co., Ltd.K072062UCP MULTIPLE DRUG SCREEN TEST CUPSUcp Biosciences, Inc.K061457UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTSUcp Biosciences, Inc.K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICEACON Laboratories, Inc.K011545VERDICT -II TCA, VERDICT-II MTDMedtox Diagnostics, Inc.K870823EMIT NORTRIPTYLINE ASSAYSyva Co.

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.

↑