FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PR-3 ELISA TEST SYSTEM
K Number: K961764
·
Decision Aug 19, 1996
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
73
Applicant Total
14
Review Days
104
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Basic Information
- Device Name
- PR-3 ELISA TEST SYSTEM
- K Number
- K961764
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunoprobe, Inc.
- Date Received
- May 7, 1996
- Decision Date
- August 19, 1996
- Product Code
- MOB
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | FDA class 2 | Immunology |
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Other Clearances by Immunoprobe, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972406 | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM | Dec 22, 1997 | Substantially Equivalent |
| K971393 | MYCOPLASMA IGG ELISA TEST SYSTEM | Jul 14, 1997 | Substantially Equivalent |
| K961765 | MPO ELISA TEST SYSTEM | Aug 19, 1996 | Substantially Equivalent |
| K951549 | EBNA IGG EIA TEST SYSTEM | Apr 29, 1996 | Substantially Equivalent |
| K952522 | CARDIOLIPIN IGA EIA TEST SYSTEM | Feb 9, 1996 | Substantially Equivalent |
| K952523 | CARDIOLIPIN IGG EIA TEST KIT | Feb 9, 1996 | Substantially Equivalent |
| K952521 | CARDIOLIPIN IGM EIA TEST SYSTEM | Feb 9, 1996 | Substantially Equivalent |
| K951364 | MICROSOMAL EIA TEST KIT | Nov 20, 1995 | Substantially Equivalent |
| K951362 | THYROGLOBULIN EIA TEST KIT | Nov 20, 1995 | Substantially Equivalent |
| K951363 | CARDIOLIPIN IGG,M,A EIA TEST SYSTEM | Oct 13, 1995 | Substantially Equivalent |