Data-Tope Tri-Rac Radioassay Control
FDA 510(k) K790264 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK790264
Submission
- Device name
- Data-Tope Tri-Rac Radioassay Control
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- February 6, 1979
- Decision date
- March 21, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K800296 | Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional | 03/05/1980SE |
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| K792723 | Blood Fluid FiltersJKA · Traditional | 01/21/1980SE |
| K792607 | T3 Uptake (T3U) ReagentsKHQ · Traditional | 01/16/1980SE |
| K792443 | TSH RadioimmunoassayJLW · Traditional | 12/27/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | 12/18/1979SE |
| K791922 | Harleco Brand Clinicard Lipase Test SetCET · Traditional | 11/27/1979SE |
| K792183 | Dade High Density Lipoprotein CholesteroLBS · Traditional | 11/13/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | 05/23/1979SE |
| K790767 | Immu-Tek Automatic CentrifugeKSN · Traditional | 05/23/1979SE |
Questions and answers
When was Data-Tope Tri-Rac Radioassay Control cleared by the FDA?
Data-Tope Tri-Rac Radioassay Control (K790264) received a 510(k) decision of Substantially Equivalent on March 21, 1979, 43 days after the submission was received.
What is the product code of K790264?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.