Enzymatic CO2 Reagent, Modification
FDA 510(k) K932267 · Intersect Systems, Inc.
510(k) numberK932267
Submission
- Device name
- Enzymatic CO2 Reagent, Modification
- Applicant
- Intersect Systems, Inc.
Longview, WA, US - Received
- April 14, 1993
- Decision date
- September 24, 1993
- 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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More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
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| K011692 | Homogeneous Enzymic Homocysteine ReagentLPS · Traditional | 07/25/2001SE |
| K003892 | Total Bilirubin ReagentCIG · Traditional | 02/20/2001SE |
| K983937 | Dual Vial Creatinine ReagentCGX · Traditional | 01/06/1999SE |
| K974833 | Ck-Nac ReagentCGS · Traditional | 02/13/1998SE |
| K941807 | Intersect Systems' Non-Mercuric Chloride ReagentCHG · Traditional | 09/14/1994SE |
| K932888 | Intersect Systems Direct Amylase ReagentJFJ · Traditional | 01/31/1994SE |
| K934039 | Intersect Systems HDL Cholesterol Reagent SetLBR · Traditional | 11/16/1993SE |
| K913225 | Urine/Csf Microprotein ReagentCEK · Traditional | 10/11/1991SE |
Questions and answers
When was Enzymatic CO2 Reagent, Modification cleared by the FDA?
Enzymatic CO2 Reagent, Modification (K932267) received a 510(k) decision of Substantially Equivalent on September 24, 1993, 163 days after the submission was received.
What is the product code of K932267?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.