Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109UL
FDA 510(k) K002551 · Dade Behring, Inc.
510(k) numberK002551
Submission
- Device name
- Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109UL
- Applicant
- Dade Behring, Inc.
San Jose, CA, US - Received
- August 17, 2000
- Decision date
- October 11, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LEG – Enzyme Immunoassay, Valproic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3645
- Specialty
- Clinical Toxicology
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Questions and answers
When was Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109UL cleared by the FDA?
Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109UL (K002551) received a 510(k) decision of Substantially Equivalent on October 11, 2000, 55 days after the submission was received.
What is the product code of K002551?
The FDA product code is LEG – Enzyme Immunoassay, Valproic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.3645.