Urinary/Cebrospinal Fluid Protein Calibrator
FDA 510(k) K934843 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK934843
Submission
- Device name
- Urinary/Cebrospinal Fluid Protein Calibrator
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- October 8, 1993
- Decision date
- March 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Urinary/Cebrospinal Fluid Protein Calibrator cleared by the FDA?
Urinary/Cebrospinal Fluid Protein Calibrator (K934843) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 154 days after the submission was received.
What is the product code of K934843?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.