Abbott Testpack Plus H. Pylori
FDA 510(k) K982362 · Abbott Laboratories
510(k) numberK982362
Submission
- Device name
- Abbott Testpack Plus H. Pylori
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- July 6, 1998
- Decision date
- November 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Abbott Testpack Plus H. Pylori cleared by the FDA?
Abbott Testpack Plus H. Pylori (K982362) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 135 days after the submission was received.
What is the product code of K982362?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.