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FDA 510(k)

NICOLET VERSALAB

K-Number: K010521 · 2001-03-09

ApplicantNicolet Biomedical
Decision Date2001-03-09
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NICOLET VERSALAB is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical. It received FDA 510(k) clearance on 2001-03-09 under 510(k) number K010521. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICOLET VERSALAB?

NICOLET VERSALAB is a medical device that received FDA 510(k) clearance on 2001-03-09. The listed applicant is Nicolet Biomedical. The 510(k) number is K010521.

When did NICOLET VERSALAB receive FDA 510(k) clearance?

NICOLET VERSALAB received FDA 510(k) clearance on 2001-03-09, under 510(k) number K010521.

Who is the listed applicant for NICOLET VERSALAB?

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

What is the FDA product code for NICOLET VERSALAB?

The FDA product code for NICOLET VERSALAB is JAF.

Related Clinical Trials

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Other records listing Nicolet Biomedical 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.

K020754NICOLET PIONEER TC8080K013281VERSALAB APMK013419NICOLET ELECTROMAGNETIC NAVIGATION SYSTEMK011135GSI AUDERAK002766NICOLET VASOGUARDK993939NICOLET EME LEGEND TC22

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Related Devices (Code: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.K090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.

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.

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