Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12
FDA 510(k) K042362 · Diagnostic Chemicals , Ltd.
510(k) numberK042362
Submission
- Device name
- Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E., CA - Received
- August 31, 2004
- Decision date
- December 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KHS – Enzymatic, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
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Questions and answers
When was Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12 cleared by the FDA?
Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12 (K042362) received a 510(k) decision of Substantially Equivalent on December 27, 2004, 118 days after the submission was received.
What is the product code of K042362?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.