FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
K Number: K861167
·
Decision Apr 25, 1986
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
53
Applicant Total
18
Review Days
28
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Basic Information
- Device Name
- IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST
- K Number
- K861167
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Atlantic Antibodies
- Date Received
- March 28, 1986
- Decision Date
- April 25, 1986
- Product Code
- CZP
- 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 |
|---|---|---|---|
| CZP | Iga, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CZP), ordered by most recent decision date.
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WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
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IGA
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Other Clearances by Atlantic Antibodies
| K Number | Device Name | ||
|---|---|---|---|
| K892526 | SPQ TM TEST SYSTEM II FOR CRP | May 9, 1989 | Substantially Equivalent |
| K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B | Mar 16, 1989 | Substantially Equivalent |
| K890563 | SPQ(TM) ANTIBODY REAGENT SET II FOR TRF | Mar 3, 1989 | Substantially Equivalent |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | Feb 23, 1989 | Substantially Equivalent |
| K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | Feb 22, 1989 | Substantially Equivalent |
| K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG | Feb 22, 1989 | Substantially Equivalent |
| K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | Feb 17, 1989 | Substantially Equivalent |
| K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | Feb 17, 1989 | Substantially Equivalent |
| K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | Feb 17, 1989 | Substantially Equivalent |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | Feb 15, 1989 | Substantially Equivalent |