FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
K Number: K883670
·
Decision Apr 28, 1989
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
19
Applicant Total
9
Review Days
253
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Basic Information
- Device Name
- SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
- K Number
- K883670
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Electro-Nucleonics, Inc.
- Date Received
- August 18, 1988
- Decision Date
- April 28, 1989
- Product Code
- GNP
- 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 |
|---|---|---|---|
| GNP | Antiserum, Cf, Epstein-Barr Virus | FDA class 1 | Microbiology |
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Other Clearances by Electro-Nucleonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893718 | DELTATEST (R) LIPASE II | Sep 28, 1989 | Substantially Equivalent |
| K883281 | VIRGO HSV-2 IGG ELISA | Mar 10, 1989 | Substantially Equivalent |
| K883427 | VIRGO(R) VZV-IGG ELISA | Mar 10, 1989 | Substantially Equivalent |
| K883282 | VIRGO HSV-1 IGG ELISA | Mar 10, 1989 | Substantially Equivalent |
| K883102 | VIRGO (R) CMV-IGG ELISA | Feb 8, 1989 | Substantially Equivalent |
| K884784 | VIRGO(R) MICROWELL ALT ASSAY | Dec 29, 1988 | Substantially Equivalent |
| K883205 | ALTLTS ALANINE AMINO TRANSFERASE ALT | Sep 9, 1988 | Substantially Equivalent |
| K883206 | LACTATE DEHYDROGENASE LDH | Sep 9, 1988 | Substantially Equivalent |