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)

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

K-Number: K083744 · 2009-09-01

ApplicantBinax, Inc.
Decision Date2009-09-01
Product CodeMJZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 2009-09-01 under 510(k) number K083744. The device is classified under product code MJZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010?

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 is a medical device that received FDA 510(k) clearance on 2009-09-01. The listed applicant is Binax, Inc.. The 510(k) number is K083744.

When did BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 receive FDA 510(k) clearance?

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 received FDA 510(k) clearance on 2009-09-01, under 510(k) number K083744.

Who is the listed applicant for BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010?

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

What is the FDA product code for BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010?

The FDA product code for BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 is MJZ.

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 Binax, 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.

K090301BINAXNOW PBP2A TEST, MODEL 890-000K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTK091489CLEARVIEW ADVANCED STREP A , MODEL 737-430K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TESTK080003BINAXNOW G6PD TEST

View all 30 devices →

Related Devices (Code: MJZ)

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.

K972182ABBOTT STREP A CONTROLSAbbott DiagnosticsK972129CHLAMYDIATROL AGBlackhawk Biosystems, 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.

↑