HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0— 510(k) K990250
Substantially EquivalentMorax
FDA 510(k) clearance K990250 for HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0, Substantially Equivalent on 1999-06-18. Applicant: Morax. Device class: 1.
Clearance details
- Applicant
- Morax
- Product code
- Code LBT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chelsea, MI, US
Recent devices under product code LBT
view allMore clearances from Morax
view all- K033277 — HYDRAGEL CSF ISOFOCUSING KITS
- K012789 — MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
- K992148 — HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
- K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
- K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207
Data sourced from openFDA. This site is unofficial and independent of the FDA.