FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABBOTT TESTPACK PLUS H. PYLORI
K Number: K982362
·
Decision Nov 18, 1998
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
883
Review Days
135
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ABBOTT TESTPACK PLUS H. PYLORI
- K Number
- K982362
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- July 6, 1998
- Decision Date
- November 18, 1998
- Product Code
- LYR
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYR | Helicobacter Pylori | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYR), ordered by most recent decision date.
Hp Detect Stool Antigen ELISA
FDA 510(k)
FDA Class 1
·Microbiology
Premier HpSA Flex (619096)
FDA 510(k)
FDA Class 1
·Microbiology
Curian HpSA, Curian Analyzer
FDA 510(k)
FDA Class 1
·Microbiology
Vstrip H. pylori Antigen Rapid Test
FDA 510(k)
FDA Class 1
·Microbiology
PREMIER Platinum HpSA PLUS
FDA 510(k)
FDA Class 1
·Microbiology
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Abbott Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252424 | Anti-HCV Next | Apr 28, 2026 | Substantially Equivalent |
| K243500 | ARCHITECT iGentamicin | Jul 9, 2025 | Substantially Equivalent |
| K243168 | Alinity i Rubella IgG | Jun 20, 2025 | Substantially Equivalent |
| K243283 | Alinity h-series System | Feb 20, 2025 | Substantially Equivalent |
| K233932 | Alinity i Toxo IgM | Aug 30, 2024 | Substantially Equivalent |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent |
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K220031 | Alinity h-series System | Aug 4, 2023 | Substantially Equivalent |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Jul 14, 2023 | Substantially Equivalent |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Jun 5, 2023 | Substantially Equivalent |