FDA 510(k)

QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1

K-Number: K981687 · 1998-06-03

Decision Date1998-06-03

Product CodeJXM

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 1998-06-03 under 510(k) number K981687. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1?

QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 is a medical device that received FDA 510(k) clearance on 1998-06-03. The listed applicant is Phamatech. The 510(k) number is K981687.

When did QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 receive FDA 510(k) clearance?

QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 received FDA 510(k) clearance on 1998-06-03, under 510(k) number K981687.

Who is the listed applicant for QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1?

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 QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1?

The FDA product code for QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 is JXM.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Phamatech as applicant

K041578QUICKSCREEN, MODELS 9177X AND 9178X K030447AT HOME DRUG CUP, MODEL 9150X K010833AT WORK DRUG TEST, MODEL 9177T AWT K010836AT WORK DRUG TEST, MODEL 9147T AWT K010655AT HOME DRUG TESTT, MODEL 9150 T K010653AT HOME DRUG TEST, MODEL 9068 T

View all 47 devices →

Related Devices (Code: JXM)

K243498Alinity c Benzodiazepines Reagent KitMicrogenics Corporation K221765ONLINE DAT Benzodiazepines IIRoche Diagnostics K190968CEDIA Benzodiazepine AssayMicrogenics Corporation K173963DRI Benzodiazepine AssayMicrogenics Corporation K163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics Corporation K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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.