Bi-Level Acetaminophen-Salicylate CNRL
FDA 510(k) K813349 · Stanbio Laboratory
510(k) numberK813349
Submission
- Device name
- Bi-Level Acetaminophen-Salicylate CNRL
- Applicant
- Stanbio Laboratory
Mchenry, IL, US - Received
- November 27, 1981
- Decision date
- December 22, 1981
- 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 Bi-Level Acetaminophen-Salicylate CNRL cleared by the FDA?
Bi-Level Acetaminophen-Salicylate CNRL (K813349) received a 510(k) decision of Substantially Equivalent on December 22, 1981, 25 days after the submission was received.
What is the product code of K813349?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.