Digitoxin Fpia Calibrator Set
FDA 510(k) K915464 · Sigma Diagnostics, Inc.
510(k) numberK915464
Submission
- Device name
- Digitoxin Fpia Calibrator Set
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- December 2, 1991
- Decision date
- January 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Digitoxin Fpia Calibrator Set cleared by the FDA?
Digitoxin Fpia Calibrator Set (K915464) received a 510(k) decision of Substantially Equivalent on January 15, 1992, 44 days after the submission was received.
What is the product code of K915464?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.