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)

CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST

K-Number: K981882 · 1998-07-06

ApplicantPrinceton BioMeditech Corp.
Decision Date1998-07-06
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 1998-07-06 under 510(k) number K981882. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST?

CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST is a medical device that received FDA 510(k) clearance on 1998-07-06. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K981882.

When did CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST receive FDA 510(k) clearance?

CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST received FDA 510(k) clearance on 1998-07-06, under 510(k) number K981882.

Who is the listed applicant for CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST?

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

What is the FDA product code for CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST?

The FDA product code for CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST is MMI.

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 Princeton BioMeditech 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.

K251538Status™ COVID-19/Flu A&BK182157BioSign Flu A+BK133474BIOSIGN FLU A + B, STATUS FLU A & BK132465BIOSIGN FLU A + B, STATUS FLU A & BK083746BIOSIGN FLU A+BK100817BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

View all 71 devices →

Related Devices (Code: MMI)

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.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, 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.

↑