FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇭 Switzerland
PRONTO DRY
K Number: K991248
·
Decision Jun 22, 1999
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
2
Review Days
71
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
- PRONTO DRY
- K Number
- K991248
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Instruments Corporation Mic AG
- Date Received
- April 12, 1999
- Decision Date
- June 22, 1999
- 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 Medical Instruments Corporation Mic AG
| K Number | Device Name | ||
|---|---|---|---|
| K950087 | LOT 440 | Feb 6, 1996 | Substantially Equivalent |