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FDA 510(k)

NANOSEP N10

K-Number: K935496 · 1994-04-26

ApplicantIntersep , Ltd.
Decision Date1994-04-26
Product CodeJJH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NANOSEP N10 is the device name listed in this FDA 510(k) record. The listed applicant is Intersep , Ltd.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K935496. The device is classified under product code JJH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NANOSEP N10?

NANOSEP N10 is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Intersep , Ltd.. The 510(k) number is K935496.

When did NANOSEP N10 receive FDA 510(k) clearance?

NANOSEP N10 received FDA 510(k) clearance on 1994-04-26, under 510(k) number K935496.

Who is the listed applicant for NANOSEP N10?

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

What is the FDA product code for NANOSEP N10?

The FDA product code for NANOSEP N10 is JJH.

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Related Devices (Code: JJH)

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.

K113731ESENSOR RESPIRATORY VIRAL PANELClinical Micro Sensors, Inc.K960298VIVASPIN 4 10,000 MWVivascience, Inc.K943966VIVAPORE 2Vivascience, Inc.K943965VIVAPORE 10Vivascience, Inc.K941326ULTRAFREE-CLMillipore Corp.K930168CENTRICON -50 CONCENTRATORAmicon, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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