Dupont Aca(R) Urine Druge Os Abuse Control
FDA 510(k) K952412 · Dupont Medical Products
510(k) numberK952412
Submission
- Device name
- Dupont Aca(R) Urine Druge Os Abuse Control
- Applicant
- Dupont Medical Products
Newark, DE, US - Received
- May 23, 1995
- Decision date
- June 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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| K941050 | Dupont Aca StarJJQ · Traditional | 11/10/1994SE |
| K943996 | Dupont Aca Plus Luteinizing Hormone (LH) MethodCEP · Traditional | 10/20/1994SE |
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Questions and answers
When was Dupont Aca(R) Urine Druge Os Abuse Control cleared by the FDA?
Dupont Aca(R) Urine Druge Os Abuse Control (K952412) received a 510(k) decision of Substantially Equivalent on June 23, 1995, 31 days after the submission was received.
What is the product code of K952412?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.