Cedia Digoxin Calibrators
FDA 510(k) K972433 · Boehringer Mannheim Corp.
510(k) numberK972433
Submission
- Device name
- Cedia Digoxin Calibrators
- Applicant
- Boehringer Mannheim Corp.
Concord, CA, US - Received
- June 30, 1997
- Decision date
- July 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Cedia Digoxin Calibrators cleared by the FDA?
Cedia Digoxin Calibrators (K972433) received a 510(k) decision of Substantially Equivalent on July 24, 1997, 24 days after the submission was received.
What is the product code of K972433?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.