Target Isocheck Control Serum
FDA 510(k) K821183 · Smithkline Diagnostics, Inc.
510(k) numberK821183
Submission
- Device name
- Target Isocheck Control Serum
- Applicant
- Smithkline Diagnostics, Inc.
Mchenry, IL, US - Received
- April 27, 1982
- Decision date
- May 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K993723 | Cardiasure Cardiac Markers ControlJJT · Traditional | Quantimetrix Corp. | 11/23/1999SE |
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| K984437 | Quantex Aso-Crp-Rp Control IIJJT · Traditional | Instrumentation Laboratory CO | 02/02/1999SE |
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| K821884 | Gastroccult TMKHE · Traditional | 10/08/1982SE |
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Questions and answers
When was Target Isocheck Control Serum cleared by the FDA?
Target Isocheck Control Serum (K821183) received a 510(k) decision of Substantially Equivalent on May 14, 1982, 17 days after the submission was received.
What is the product code of K821183?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.