Helicobacter Pylori Igg Elisa Test System
FDA 510(k) K980821 · Zeus Scientific, Inc.
510(k) numberK980821
Submission
- Device name
- Helicobacter Pylori Igg Elisa Test System
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- March 3, 1998
- Decision date
- July 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LYR – Helicobacter Pylori
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
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Questions and answers
When was Helicobacter Pylori Igg Elisa Test System cleared by the FDA?
Helicobacter Pylori Igg Elisa Test System (K980821) received a 510(k) decision of Substantially Equivalent on July 30, 1998, 149 days after the submission was received.
What is the product code of K980821?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.