Randox Theophylline
FDA 510(k) K011771 · Randox Laboratories, Ltd.
510(k) numberK011771
Submission
- Device name
- Randox Theophylline
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- June 6, 2001
- Decision date
- January 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KLS – Enzyme Immunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Specialty
- Clinical Toxicology
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Questions and answers
When was Randox Theophylline cleared by the FDA?
Randox Theophylline (K011771) received a 510(k) decision of Substantially Equivalent on January 17, 2002, 225 days after the submission was received.
What is the product code of K011771?
The FDA product code is KLS – Enzyme Immunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.