Human Serum Anticonvulsant Drug Control
FDA 510(k) K843818 · Quantimetrix Corp.
510(k) numberK843818
Submission
- Device name
- Human Serum Anticonvulsant Drug Control
- Applicant
- Quantimetrix Corp.
Hawthorne, CA, US - Received
- September 28, 1984
- Decision date
- October 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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Questions and answers
When was Human Serum Anticonvulsant Drug Control cleared by the FDA?
Human Serum Anticonvulsant Drug Control (K843818) received a 510(k) decision of Substantially Equivalent on October 30, 1984, 32 days after the submission was received.
What is the product code of K843818?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.