Emit 2000 Vancomycin Calibrators
FDA 510(k) K020845 · Dade Behring, Inc.
510(k) numberK020845
Submission
- Device name
- Emit 2000 Vancomycin Calibrators
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- March 15, 2002
- Decision date
- May 8, 2002
- 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 Emit 2000 Vancomycin Calibrators cleared by the FDA?
Emit 2000 Vancomycin Calibrators (K020845) received a 510(k) decision of Substantially Equivalent on May 8, 2002, 54 days after the submission was received.
What is the product code of K020845?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.