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

FDA 510(k)

HYDRAGEL 7,15,30, CHOL-HDL KIT

K-Number: K972015 · 1997-10-27

ApplicantMorax
Decision Date1997-10-27
Product CodeLBT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYDRAGEL 7,15,30, CHOL-HDL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Morax. It received FDA 510(k) clearance on 1997-10-27 under 510(k) number K972015. 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 7,15,30, CHOL-HDL KIT?

HYDRAGEL 7,15,30, CHOL-HDL KIT is a medical device that received FDA 510(k) clearance on 1997-10-27. The listed applicant is Morax. The 510(k) number is K972015.

When did HYDRAGEL 7,15,30, CHOL-HDL KIT receive FDA 510(k) clearance?

HYDRAGEL 7,15,30, CHOL-HDL KIT received FDA 510(k) clearance on 1997-10-27, under 510(k) number K972015.

Who is the listed applicant for HYDRAGEL 7,15,30, CHOL-HDL KIT?

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 7,15,30, CHOL-HDL KIT?

The FDA product code for HYDRAGEL 7,15,30, CHOL-HDL KIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Morax as applicant

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.

K033277HYDRAGEL CSF ISOFOCUSING KITSK012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123K992148HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KITK991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)K990250HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0K974854HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207

View all 12 devices →

Related Devices (Code: LBT)

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.

K000568HDL CHOLESTEROL PLUSRoche Diagnostics Corp.K990250HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0MoraxK904035REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEMHelena LaboratoriesK894366REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187Helena LaboratoriesK882368REP HDL ELECTROPHORESIS METHODHelena LaboratoriesK873547TITAN 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.

↑