Abusign DOA4
FDA 510(k) K943439 · Princeton BioMeditech Corp.
510(k) numberK943439
Submission
- Device name
- Abusign DOA4
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- July 18, 1994
- Decision date
- February 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Abusign DOA4 cleared by the FDA?
Abusign DOA4 (K943439) received a 510(k) decision of Substantially Equivalent on February 22, 1995, 219 days after the submission was received.
What is the product code of K943439?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.