Randox Human Asssayed Drug Control
FDA 510(k) K012319 · Randox Laboratories, Ltd.
510(k) numberK012319
Submission
- Device name
- Randox Human Asssayed Drug Control
- Applicant
- Randox Laboratories, Ltd.
Crumlin, Co. Antrim, GB - Received
- July 23, 2001
- Decision date
- August 24, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000…DIF · Abbreviated | Roche Diagnostics Corp. | 03/25/2008SE |
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Questions and answers
When was Randox Human Asssayed Drug Control cleared by the FDA?
Randox Human Asssayed Drug Control (K012319) received a 510(k) decision of Substantially Equivalent on August 24, 2001, 32 days after the submission was received.
What is the product code of K012319?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.