FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
K Number: K002024
·
Decision Nov 22, 2000
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
1
Applicant Total
4
Review Days
142
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Basic Information
- Device Name
- PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
- K Number
- K002024
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3350
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Panbio, Inc.
- Date Received
- July 3, 2000
- Decision Date
- November 22, 2000
- Product Code
- GRY
- 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 |
|---|---|---|---|
| GRY | Antigens, All, Leptospira Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GRY), ordered by most recent decision date.
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