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)

FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE

K-Number: K122064 · 2013-05-07

ApplicantTianjin New Bay Bioresearch Co., Ltd.
Decision Date2013-05-07
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin New Bay Bioresearch Co., Ltd.. It received FDA 510(k) clearance on 2013-05-07 under 510(k) number K122064. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE?

FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE is a medical device that received FDA 510(k) clearance on 2013-05-07. The listed applicant is Tianjin New Bay Bioresearch Co., Ltd.. The 510(k) number is K122064.

When did FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE receive FDA 510(k) clearance?

FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE received FDA 510(k) clearance on 2013-05-07, under 510(k) number K122064.

Who is the listed applicant for FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE?

The FDA 510(k) record lists Tianjin New Bay Bioresearch Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE?

The FDA product code for FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE is DJG.

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 Tianjin New Bay Bioresearch Co., Ltd. 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.

K130275QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TESTK112449QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TESTK071489HOMECHECK MULTIPLE DRUG CUP TESTK073431FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME TK061617FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TESTK052520RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC

View all 11 devices →

Related Devices (Code: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

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.

↑