FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANA TEST
K Number: K771064
·
Decision Jun 24, 1977
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
57
Review Days
11
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Basic Information
- Device Name
- ANA TEST
- K Number
- K771064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Gull Laboratories, Inc.
- Date Received
- June 13, 1977
- Decision Date
- June 24, 1977
- 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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|---|---|---|---|
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| K940093 | EBV-EA(D) IGG ELISA TEST | Sep 15, 1995 | Substantially Equivalent |
| K941046 | VZV IGG ELISA TEST | Aug 24, 1995 | Substantially Equivalent |
| K941198 | EBV LGG ELISA TEST | Aug 23, 1995 | Substantially Equivalent |
| K932333 | PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR | Aug 15, 1995 | Substantially Equivalent |
| K941624 | RUBELLA IGG ELISA TEST | Aug 4, 1995 | Substantially Equivalent |
| K922758 | HSV-1 IGM ELISA TEST -- MODIFICATION | Oct 5, 1992 | Substantially Equivalent |