FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PYLORI DETECT IGG
K Number: K973508
·
Decision Mar 10, 1998
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
11
Review Days
175
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
- PYLORI DETECT IGG
- K Number
- K973508
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Detect, Inc.
- Date Received
- September 16, 1997
- Decision Date
- March 10, 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 Micro Detect, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003794 | ELISA TEST, SEROLOGY | Mar 30, 2001 | Substantially Equivalent |
| K002358 | MDI GLIADIN A TEST | Oct 19, 2000 | Substantially Equivalent |
| K002359 | MDI GLIADIN G TEST | Oct 19, 2000 | Substantially Equivalent |
| K000934 | MDI SCL-70 TEST | Apr 7, 2000 | Substantially Equivalent |
| K000477 | MDI DS-DNA TEST | Mar 1, 2000 | Substantially Equivalent |
| K994029 | MDI SM TEST | Jan 11, 2000 | Substantially Equivalent |
| K993843 | MDI RF TEST | Jan 11, 2000 | Substantially Equivalent |
| K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM | Jan 11, 2000 | Substantially Equivalent |
| K993636 | MDI SS-A TEST | Jan 10, 2000 | Substantially Equivalent |
| K993635 | MDI SM/RNP TEST | Jan 10, 2000 | Substantially Equivalent |