Cedia Dau Multi-Drug Calibrators
FDA 510(k) K980853 · Boehringer Mannheim Corp.
510(k) numberK980853
Submission
- Device name
- Cedia Dau Multi-Drug Calibrators
- Applicant
- Boehringer Mannheim Corp.
Pleasanton, CA, US - Received
- March 5, 1998
- Decision date
- April 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKB – Calibrators, Drug Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
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| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
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Questions and answers
When was Cedia Dau Multi-Drug Calibrators cleared by the FDA?
Cedia Dau Multi-Drug Calibrators (K980853) received a 510(k) decision of Substantially Equivalent on April 21, 1998, 47 days after the submission was received.
What is the product code of K980853?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.