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)

AMPHETAMINE/METHAMPHETAMINE

K-Number: K012998 · 2002-03-13

ApplicantAbbott Laboratories
Decision Date2002-03-13
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMPHETAMINE/METHAMPHETAMINE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2002-03-13 under 510(k) number K012998. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPHETAMINE/METHAMPHETAMINE?

AMPHETAMINE/METHAMPHETAMINE is a medical device that received FDA 510(k) clearance on 2002-03-13. The listed applicant is Abbott Laboratories. The 510(k) number is K012998.

When did AMPHETAMINE/METHAMPHETAMINE receive FDA 510(k) clearance?

AMPHETAMINE/METHAMPHETAMINE received FDA 510(k) clearance on 2002-03-13, under 510(k) number K012998.

Who is the listed applicant for AMPHETAMINE/METHAMPHETAMINE?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPHETAMINE/METHAMPHETAMINE?

The FDA product code for AMPHETAMINE/METHAMPHETAMINE is LAF.

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 Abbott Laboratories 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.

K262156Anti-HCV NextK252424Anti-HCV NextK243500ARCHITECT iGentamicinK243168Alinity i Rubella IgGK243283Alinity h-series SystemK233932Alinity i Toxo IgM

View all 876 devices →

Related Devices (Code: LAF)

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.

K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics CorporationK201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron GroupK170222Rapid Tox Cup IIAmerican Bio Medica Corp.K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK111927PSYCHEMEDICS METHAMPHETAMINE EIAPsychemedics Corp.

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.

↑