Labeling Change Amphetamine Double Antibody
FDA 510(k) K873755 · Diagnostic Products Corp.
510(k) numberK873755
Submission
- Device name
- Labeling Change Amphetamine Double Antibody
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- September 4, 1987
- Decision date
- October 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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Questions and answers
When was Labeling Change Amphetamine Double Antibody cleared by the FDA?
Labeling Change Amphetamine Double Antibody (K873755) received a 510(k) decision of Substantially Equivalent on October 15, 1987, 41 days after the submission was received.
What is the product code of K873755?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.