FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOIMMUNE TEST 1/2/3 SYSTEM
K Number: K833119
·
Decision Nov 21, 1983
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
18
Review Days
69
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Basic Information
- Device Name
- AUTOIMMUNE TEST 1/2/3 SYSTEM
- K Number
- K833119
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Atlantic Antibodies
- Date Received
- September 13, 1983
- Decision Date
- November 21, 1983
- Product Code
- DHN
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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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 |