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)

AT HOME DRUG TEST, MODEL 9073 T

K-Number: K010650 · 2001-03-30

ApplicantPhamatech
Decision Date2001-03-30
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AT HOME DRUG TEST, MODEL 9073 T is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 2001-03-30 under 510(k) number K010650. 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 AT HOME DRUG TEST, MODEL 9073 T?

AT HOME DRUG TEST, MODEL 9073 T is a medical device that received FDA 510(k) clearance on 2001-03-30. The listed applicant is Phamatech. The 510(k) number is K010650.

When did AT HOME DRUG TEST, MODEL 9073 T receive FDA 510(k) clearance?

AT HOME DRUG TEST, MODEL 9073 T received FDA 510(k) clearance on 2001-03-30, under 510(k) number K010650.

Who is the listed applicant for AT HOME DRUG TEST, MODEL 9073 T?

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

What is the FDA product code for AT HOME DRUG TEST, MODEL 9073 T?

The FDA product code for AT HOME DRUG TEST, MODEL 9073 T 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 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.

K041578QUICKSCREEN, MODELS 9177X AND 9178XK030447AT HOME DRUG CUP, MODEL 9150XK010833AT WORK DRUG TEST, MODEL 9177T AWTK010836AT WORK DRUG TEST, MODEL 9147T AWTK010655AT HOME DRUG TESTT, MODEL 9150 TK010653AT HOME DRUG TEST, MODEL 9068 T

View all 47 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.

↑