Data / Medical devices / United States / Indilab, Inc.
Indilab, Inc.: FDA-registered device maker in Franklin Park, IL, United States, 1 510(k) clearance
Indilab, Inc. is registered with the FDA (registration 1450962) in Franklin Park, IL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 31, 1988. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1450962
- Address
- 10367 Franklin Ave., Franklin Park, IL, United States, 60131
- Owner or operator
- INDILAB, INC. (1450962)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 20, 2008
- Registered through
- 2026
- Brand names listed
- CHEMICAL INDICATOR STRIP, Indistrip, STERRAD CHEMICAL INDICATOR STRIP, STERRAD Chemical Indicator Strip (14100)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 31, 1988 | K875193 | INDISTRIP (STERILIZATION PROCESS INDICATOR) | JOJ | Substantially Equivalent | Indilab, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 31, 1988. 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.