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)

MONOSTAR SYSTEM: IM LATEX TEST

K-Number: K861452 · 1986-05-13

ApplicantU.S. Health Resources Corp.
Decision Date1986-05-13
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONOSTAR SYSTEM: IM LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Health Resources Corp.. It received FDA 510(k) clearance on 1986-05-13 under 510(k) number K861452. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOSTAR SYSTEM: IM LATEX TEST?

MONOSTAR SYSTEM: IM LATEX TEST is a medical device that received FDA 510(k) clearance on 1986-05-13. The listed applicant is U.S. Health Resources Corp.. The 510(k) number is K861452.

When did MONOSTAR SYSTEM: IM LATEX TEST receive FDA 510(k) clearance?

MONOSTAR SYSTEM: IM LATEX TEST received FDA 510(k) clearance on 1986-05-13, under 510(k) number K861452.

Who is the listed applicant for MONOSTAR SYSTEM: IM LATEX TEST?

The FDA 510(k) record lists U.S. Health Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOSTAR SYSTEM: IM LATEX TEST?

The FDA product code for MONOSTAR SYSTEM: IM LATEX TEST is KTN.

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 U.S. Health Resources Corp. 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.

K861731NATURAL DETECTOR SYSTEM

Related Devices (Code: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

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.

↑