Immulite Opiates Screen/Control Module
FDA 510(k) K962323 · Diagnostic Products Corp.
510(k) numberK962323
Submission
- Device name
- Immulite Opiates Screen/Control Module
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- June 17, 1996
- Decision date
- March 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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Questions and answers
When was Immulite Opiates Screen/Control Module cleared by the FDA?
Immulite Opiates Screen/Control Module (K962323) received a 510(k) decision of Substantially Equivalent on March 10, 1997, 266 days after the submission was received.
What is the product code of K962323?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.