Labone Micro-Plate Cotinine Eia
FDA 510(k) K033601 · Labone, Inc.
510(k) numberK033601
Submission
- Device name
- Labone Micro-Plate Cotinine Eia
- Applicant
- Labone, Inc.
Lenexa, KS, US - Received
- November 14, 2003
- Decision date
- February 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Labone Micro-Plate Cotinine Eia cleared by the FDA?
Labone Micro-Plate Cotinine Eia (K033601) received a 510(k) decision of Substantially Equivalent on February 10, 2004, 88 days after the submission was received.
What is the product code of K033601?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.