Digoxin Fpia Calibrators
FDA 510(k) K872328 · Sigma Chemical Co.
510(k) numberK872328
Submission
- Device name
- Digoxin Fpia Calibrators
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- June 17, 1987
- Decision date
- July 7, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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Questions and answers
When was Digoxin Fpia Calibrators cleared by the FDA?
Digoxin Fpia Calibrators (K872328) received a 510(k) decision of Substantially Equivalent on July 7, 1987, 20 days after the submission was received.
What is the product code of K872328?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.