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)

REDI-TEST METHAMPHETAMINE

K-Number: K991504 · 1999-07-22

ApplicantRedwood Biotech, Inc.
Decision Date1999-07-22
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

REDI-TEST METHAMPHETAMINE is the device name listed in this FDA 510(k) record. The listed applicant is Redwood Biotech, Inc.. It received FDA 510(k) clearance on 1999-07-22 under 510(k) number K991504. 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 REDI-TEST METHAMPHETAMINE?

REDI-TEST METHAMPHETAMINE is a medical device that received FDA 510(k) clearance on 1999-07-22. The listed applicant is Redwood Biotech, Inc.. The 510(k) number is K991504.

When did REDI-TEST METHAMPHETAMINE receive FDA 510(k) clearance?

REDI-TEST METHAMPHETAMINE received FDA 510(k) clearance on 1999-07-22, under 510(k) number K991504.

Who is the listed applicant for REDI-TEST METHAMPHETAMINE?

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

What is the FDA product code for REDI-TEST METHAMPHETAMINE?

The FDA product code for REDI-TEST 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 Redwood Biotech, 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.

K000979REDI-SCREENK993100REDI-SCREENK991698REDI-TEST PCPK991110REDI-TEST COCAINEK990870REDI-TEST THC

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.

↑