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FDA 510(k)

Continuous Single Culture -NX (CSCM-NX)

K-Number: K170681 · 2017-06-08

ApplicantIrvine Scientific Sales Co., Inc.
Decision Date2017-06-08
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Continuous Single Culture -NX (CSCM-NX) is a medical device manufactured by Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 2017-06-08 under approval number K170681. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Continuous Single Culture -NX (CSCM-NX)?

Continuous Single Culture -NX (CSCM-NX) is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Irvine Scientific Sales Co., Inc.. The 510(k) number is K170681.

When was Continuous Single Culture -NX (CSCM-NX) approved by the FDA?

Continuous Single Culture -NX (CSCM-NX) received FDA 510(k) clearance on 2017-06-08, under approval number K170681.

What company makes Continuous Single Culture -NX (CSCM-NX)?

Continuous Single Culture -NX (CSCM-NX) is manufactured by Irvine Scientific Sales Co., Inc..

What is the FDA product code for Continuous Single Culture -NX (CSCM-NX)?

The FDA product code for Continuous Single Culture -NX (CSCM-NX) is MQL.

Related Clinical Trials

NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT06888687 Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes. ACTIVE_NOT_RECRUITING NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING NCT07602036 Type 2 Diabetes and Pregnancy a Single-arm Interventional Study NOT_YET_RECRUITING NCT07430358 Obstetric Risk Assessment & Cesarean-delivery in Labor Estimation Using Artificial Intelligence RECRUITING NCT07336654 Circadian Rhythm Monitoring Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41529615 Wearable microneedle sensors for continuous interstitial fluid monitoring. Biosensors & bioelectronics (2026)

Other Devices by Irvine Scientific Sales Co., Inc.

K171224Arctic Sperm Cryopreservation Medium K170602Continuous Single Culture-NX Complete (CSCM-NXC)

Related Devices (Code: MQL)

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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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