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)

QUICKPAC II ONE STEP COCAINE TEST

K-Number: K992990 · 1999-09-20

ApplicantSyntron Bioresearch, Inc.
Decision Date1999-09-20
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUICKPAC II ONE STEP COCAINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Syntron Bioresearch, Inc.. It received FDA 510(k) clearance on 1999-09-20 under 510(k) number K992990. 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 QUICKPAC II ONE STEP COCAINE TEST?

QUICKPAC II ONE STEP COCAINE TEST is a medical device that received FDA 510(k) clearance on 1999-09-20. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K992990.

When did QUICKPAC II ONE STEP COCAINE TEST receive FDA 510(k) clearance?

QUICKPAC II ONE STEP COCAINE TEST received FDA 510(k) clearance on 1999-09-20, under 510(k) number K992990.

Who is the listed applicant for QUICKPAC II ONE STEP COCAINE TEST?

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

What is the FDA product code for QUICKPAC II ONE STEP COCAINE TEST?

The FDA product code for QUICKPAC II ONE STEP COCAINE 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 Syntron Bioresearch, 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.

K993490QUICKSTRIP ONE STEP OPIATES TESTK993491QUICKPAC II ONE STEP OPIATES TESTK992748DRUGCHECK X MULTIDRUG SCREENING DEVICEK992207QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEMK990325QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICEK983113BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT

View all 26 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.

↑