Identifiers
- 510(k) Number
- K830472 FDA 510(k)
- FDA Product Code
- JKA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Liposol is a device in the Clinical Chemistry advisory committee category, identified by the product code JKA. It received FDA 510(k) clearance as substantially equivalent through a traditional review process.
The device was manufactured by Quest Medical, Inc., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States. The application was received on February 15, 1983, and clearance was granted on June 8, 1983, under k-number K830472.
Frequently asked questions
What is the Liposol device used for?
Liposol is a device classified under the Clinical Chemistry advisory committee category, identified by product code JKA, indicating its use in clinical chemistry testing environments as determined by its regulatory classification.
How was the Liposol device cleared for market?
Liposol received FDA 510(k) clearance through a traditional review process, being found substantially equivalent to a predicate device, which allowed it to be marketed based on that equivalence determination.
Who manufactures the Liposol device and where are they located?
The Liposol device is manufactured by Quest Medical, Inc., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as specified in the device’s authorization records.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Liposol 510 (k) FDA Premarket Notification K830472 QUEST MEDICAL, INC., LIPOSOL (K830472) — FDA 510 (k) | Innolitics, Company | Nordson MEDICAL, Company Profile - Quest Medical Inc - ChemDmart, Brands | Nordson MEDICAL
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K830472 | Class II | Active |
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Manufacturer
- Manufacturer
- Quest Medical Inc
- FDA Applicant
- Quest Medical, Inc.
Sources (1)
- FDA 510(k) K830472 24 fields · synced Sep 24, 2026