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)

AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA

K-Number: K931151 · 1993-06-18

ApplicantMicroprobe Corp.
Decision Date1993-06-18
Product CodeMLA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA is the device name listed in this FDA 510(k) record. The listed applicant is Microprobe Corp.. It received FDA 510(k) clearance on 1993-06-18 under 510(k) number K931151. The device is classified under product code MLA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA?

AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA is a medical device that received FDA 510(k) clearance on 1993-06-18. The listed applicant is Microprobe Corp.. The 510(k) number is K931151.

When did AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA receive FDA 510(k) clearance?

AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA received FDA 510(k) clearance on 1993-06-18, under 510(k) number K931151.

Who is the listed applicant for AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA?

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

What is the FDA product code for AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA?

The FDA product code for AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA is MLA.

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 Microprobe 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.

K931374AFFIRM VPIII MICROBIAL IDENTIFICATION TESTK922457AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINAK923133AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALISK920536AFFIRM VP SAMPLE COLLECTION SETK923268AFFIRM PROCESSOR

Related Devices (Code: MLA)

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.

K931374AFFIRM VPIII MICROBIAL IDENTIFICATION TESTMicroprobe 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.

↑