FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DETECTADOT SYSTEM 2000 CMV IGG TEST
K Number: K875159
·
Decision May 6, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
17
Applicant Total
57
Review Days
142
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Basic Information
- Device Name
- DETECTADOT SYSTEM 2000 CMV IGG TEST
- K Number
- K875159
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Gull Laboratories, Inc.
- Date Received
- December 16, 1987
- Decision Date
- May 6, 1988
- Product Code
- GQI
- 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 |
|---|---|---|---|
| GQI | Antiserum, Cf, Cytomegalovirus | FDA class 2 | Microbiology |
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|---|---|---|---|
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| K935730 | EBNA IGG ELISA TEST | Sep 19, 1995 | Substantially Equivalent |
| 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 |