Elitech Clinical Sysems Ise Control 1 and 2
FDA 510(k) K111996 · Elitechgroup
510(k) numberK111996
Submission
- Device name
- Elitech Clinical Sysems Ise Control 1 and 2
- Applicant
- Elitechgroup
Bothell, WA, US - Received
- July 13, 2011
- Decision date
- September 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K151113 | ELITech Clinical Systems CALCIUM ARSENAZOCJY · Traditional | 07/22/2015SE |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…JIX · Abbreviated | 07/08/2015SE |
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| K122177 | Elitech Clinical Systems Urine Total Protein Plus Standard 100 Mg/Dl, Elitech Clinical…JIT · Abbreviated | 02/15/2013SE |
Questions and answers
When was Elitech Clinical Sysems Ise Control 1 and 2 cleared by the FDA?
Elitech Clinical Sysems Ise Control 1 and 2 (K111996) received a 510(k) decision of Substantially Equivalent on September 14, 2011, 63 days after the submission was received.
What is the product code of K111996?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.