Randox Phencyclidine Assay
FDA 510(k) K043071 · Randox Laboratories, Ltd.
510(k) numberK043071
Submission
- Device name
- Randox Phencyclidine Assay
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- November 8, 2004
- Decision date
- January 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LCM – Enzyme Immunoassay, Phencyclidine
- Device class
- Unclassified
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Questions and answers
When was Randox Phencyclidine Assay cleared by the FDA?
Randox Phencyclidine Assay (K043071) received a 510(k) decision of Substantially Equivalent on January 27, 2005, 80 days after the submission was received.
What is the product code of K043071?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.