The Aptus (Automated) Application of the Toxoplasma Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa)F
FDA 510(k) K984317 · Zeus Scientific, Inc.
510(k) numberK984317
Submission
- Device name
- The Aptus (Automated) Application of the Toxoplasma Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa)F
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- December 3, 1998
- Decision date
- January 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
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Questions and answers
When was The Aptus (Automated) Application of the Toxoplasma Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa)F cleared by the FDA?
The Aptus (Automated) Application of the Toxoplasma Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa)F (K984317) received a 510(k) decision of Substantially Equivalent on January 22, 1999, 50 days after the submission was received.
What is the product code of K984317?
The FDA product code is LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.