Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

K-Number: K210623 · 2022-11-18

ApplicantSebia
Decision Date2022-11-18
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2022-11-18 under approval number K210623. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by Sebia. The 510(k) number is K210623.

When was FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 approved by the FDA?

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 received FDA 510(k) clearance on 2022-11-18, under approval number K210623.

What company makes FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is manufactured by Sebia.

What is the FDA product code for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2?

The FDA product code for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 is DFH.

Related Clinical Trials

NCT04456569 Geniculate Artery Embolization for Osteoarthritis ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07609186 Binaural Sound During Phacoemulsification and Posterior Chamber Lens Implantation in Geriatric Patients RECRUITING

Other Devices by Sebia

K161928CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL K171537CAPI 3 Hb A1c K162281CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) K180762CAPI 3 HEMOGLOBIN(E) K171861CAPILLARYS Hb A1c K172195HYDRASHIFT 2/4 daratumumab, daratumumab Control

View all 12 devices →

Related Devices (Code: DFH)

K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorDiazyme Laboratories K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2Siemens Healthcare Diagnostics Products GmbH K182098N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitThe Binding Site Group , Ltd. K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc. K190879N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH

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.

↑