FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PYLORI IGG ELISA TEST SYSTEM
K Number: K961221
·
Decision Jul 30, 1996
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
68
Review Days
132
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Basic Information
- Device Name
- PYLORI IGG ELISA TEST SYSTEM
- K Number
- K961221
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Armkel, LLC
- Date Received
- March 20, 1996
- Decision Date
- July 30, 1996
- 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 |
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| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Dec 21, 1999 | Substantially Equivalent |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |