Flow-Pac Triglyceride Reagent
FDA 510(k) K830957 · Amresco, Inc.
510(k) numberK830957
Submission
- Device name
- Flow-Pac Triglyceride Reagent
- Applicant
- Amresco, Inc.
Mchenry, IL, US - Received
- March 25, 1983
- Decision date
- April 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K905684 | Alkaline PhosphataseCJE · Traditional | 12/28/1990SE |
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| K905284 | Hdl-Cholesterol Precipitant 7773/7573/7473/7173LBR · Traditional | 12/11/1990SE |
| K904004 | Amrescocreat Kinase Reagent 7716/17,7516,7416,7116CGS · Traditional | 12/11/1990SE |
| K905096 | GGT Reagents, 7738, 7739, 7538, 7438 & 7138JQB · Traditional | 11/28/1990SE |
| K904381 | Diazo Colorimentry Direct BilirubinCIG · Traditional | 10/12/1990SE |
| K903775 | Creatine PhosphokinaseCGS · Traditional | 10/04/1990SE |
| K903829 | Ast ReagentCIT · Traditional | 09/25/1990SE |
Questions and answers
When was Flow-Pac Triglyceride Reagent cleared by the FDA?
Flow-Pac Triglyceride Reagent (K830957) received a 510(k) decision of Substantially Equivalent on April 18, 1983, 24 days after the submission was received.