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)

QUICKSCREEN COCAINE 150 SCREENING TEST

K-Number: K103295 · 2012-02-01

ApplicantPhamatech, Inc.
Decision Date2012-02-01
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUICKSCREEN COCAINE 150 SCREENING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech, Inc.. It received FDA 510(k) clearance on 2012-02-01 under 510(k) number K103295. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKSCREEN COCAINE 150 SCREENING TEST?

QUICKSCREEN COCAINE 150 SCREENING TEST is a medical device that received FDA 510(k) clearance on 2012-02-01. The listed applicant is Phamatech, Inc.. The 510(k) number is K103295.

When did QUICKSCREEN COCAINE 150 SCREENING TEST receive FDA 510(k) clearance?

QUICKSCREEN COCAINE 150 SCREENING TEST received FDA 510(k) clearance on 2012-02-01, under 510(k) number K103295.

Who is the listed applicant for QUICKSCREEN COCAINE 150 SCREENING TEST?

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

What is the FDA product code for QUICKSCREEN COCAINE 150 SCREENING TEST?

The FDA product code for QUICKSCREEN COCAINE 150 SCREENING TEST is DIO.

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 Phamatech, 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.

K181945QuickScreen Pro Multi Drug Screening Test, Model 9395ZK070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCK070009AT HOME DRUG TEST MODELS, 9308T AND 9308XK043599MOMENTS MENOPAUSE CHECK, MODEL 9113K043051QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121K043167PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X

View all 14 devices →

Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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.

↑