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)

STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)

K-Number: K981341 · 1998-05-22

ApplicantOraSure Technologies, Inc.
Decision Date1998-05-22
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) is the device name listed in this FDA 510(k) record. The listed applicant is OraSure Technologies, Inc.. It received FDA 510(k) clearance on 1998-05-22 under 510(k) number K981341. 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 STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)?

STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) is a medical device that received FDA 510(k) clearance on 1998-05-22. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K981341.

When did STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) receive FDA 510(k) clearance?

STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) received FDA 510(k) clearance on 1998-05-22, under 510(k) number K981341.

Who is the listed applicant for STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)?

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

What is the FDA product code for STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)?

The FDA product code for STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION) 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 OraSure Technologies, 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.

K060859COMPOUND W FREEZE OFF WART REMOVAL SYSTEMK023487HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAMEK013882OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IK020371UPLINK TEST SYSTEMK011057INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXXK002375STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I

View all 29 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.

↑