HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)— 510(k) K011113

Name: FDA 510(k) clearance K011113
Creator: U.S. Food and Drug Administration
Published: 2001-06-13

Substantially Equivalent

Sebia

FDA 510(k) clearance K011113 for HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132), Substantially Equivalent on 2001-06-13. Applicant: Sebia. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code CIN
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2001-04-11
Decision date: 2001-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsea, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIN

view all

K232904 — Access Ostase2024-04-15
K200475 — IDS-iSYS Ostase BAP2020-09-30
K043125 — ORION DIAGNOSTICA UNIQ PINP RIA2005-05-04
K020625 — SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 33462002-05-06
K994278 — ACCESS OSTASE IMMUNOENZYMETRIC ASSAY2000-03-28

More clearances from Sebia

view all

K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument2024-04-04
K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 22024-02-23
K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 22022-11-18
K203184 — HYDRASHIFT 2/4 isatuximab2021-11-12
K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera2019-11-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.