Data / Medical devices / United States / Cetylite Industries, Inc.
Cetylite Industries, Inc.: FDA-registered device maker in Pennsauken, NJ, United States, 1 510(k) clearance
Cetylite Industries, Inc. is registered with the FDA (registration 2242327) in Pennsauken, NJ, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 10, 1998. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2242327
- Address
- 9051 River Rd, Pennsauken, NJ, United States, 08110
- Owner or operator
- CETYLITE INDUSTRIES, INC. (9003459)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 5, 2003
- Registered through
- 2027
- Brand names listed
- CETYLITE POWER CLEANER, Cetylcide-G Concentrate, Varnal, Zarosen
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 10, 1998 | K974188 | CETYLCIDE-G | MED | Substantially Equivalent | Kellerandheckman | accessdata.fda.gov |
Compare with other makers
- All makers of Varnish, Cavity
- All makers of Sterilant, Medical Devices
- All makers of Cleaner, Ultrasonic, Medical Instrument
Updated September 10, 1998. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.