Chemo Dispensing Pin, Model 12495
FDA 510(k) K024239 · Abbott Laboratories
510(k) numberK024239
Submission
- Device name
- Chemo Dispensing Pin, Model 12495
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- December 23, 2002
- Decision date
- January 13, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Chemo Dispensing Pin, Model 12495 cleared by the FDA?
Chemo Dispensing Pin, Model 12495 (K024239) received a 510(k) decision of Substantially Equivalent on January 13, 2003, 21 days after the submission was received.
What is the product code of K024239?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.