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)

EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229

K-Number: K011289 · 2001-05-15

ApplicantSyva Co., Dade Behring, Inc.
Decision Date2001-05-15
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co., Dade Behring, Inc.. It received FDA 510(k) clearance on 2001-05-15 under 510(k) number K011289. 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 EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229?

EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 is a medical device that received FDA 510(k) clearance on 2001-05-15. The listed applicant is Syva Co., Dade Behring, Inc.. The 510(k) number is K011289.

When did EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 receive FDA 510(k) clearance?

EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 received FDA 510(k) clearance on 2001-05-15, under 510(k) number K011289.

Who is the listed applicant for EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229?

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

What is the FDA product code for EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229?

The FDA product code for EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 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 Syva Co., Dade Behring, 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.

K011920EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229K011300EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229K011306EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229K011161MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

View all 19 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.

↑