FDA 510(k)

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

K-Number: K990250 · 1999-06-18

ApplicantMorax

Decision Date1999-06-18

Product CodeLBT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

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 is the device name listed in this FDA 510(k) record. The listed applicant is Morax. It received FDA 510(k) clearance on 1999-06-18 under 510(k) number K990250. The device is classified under product code LBT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Morax. The 510(k) number is K990250.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 1999-06-18, under 510(k) number K990250.

Who is the listed applicant 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?

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

What is the FDA product code 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?

The FDA product code 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 is LBT.

Related Clinical Trials

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.

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Other records listing Morax as applicant

K033277HYDRAGEL CSF ISOFOCUSING KITS K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 K992148HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT K991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)K981048HYDRAGEL 6 CSF KIT K974854HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207

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Related Devices (Code: LBT)

K000568HDL CHOLESTEROL PLUSRoche Diagnostics Corp.K972015HYDRAGEL 7,15,30, CHOL-HDL KITMorax K904035REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEMHelena Laboratories K894366REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187Helena Laboratories K882368REP HDL ELECTROPHORESIS METHODHelena Laboratories K873547TITAN GEL HDL CHOLESTEROL KITHelena Laboratories

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.