FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENI ANTIBODY TO EPSTEIN-BARR VIRUS
K Number: K810860
·
Decision May 5, 1981
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
19
Applicant Total
41
Review Days
36
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ENI ANTIBODY TO EPSTEIN-BARR VIRUS
- K Number
- K810860
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Date Received
- March 30, 1981
- Decision Date
- May 5, 1981
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GNP), ordered by most recent decision date.
EBV V VCA IGM ELISA KIT MODEL# EBM-200
FDA 510(k)
FDA Class 1
·Microbiology
EBV-EBNA IGG ELISA KIT, MODEL EBG-100
FDA 510(k)
FDA Class 1
·Microbiology
EBV-VCA IGG ELISA TEST, MODEL EBG-100
FDA 510(k)
FDA Class 1
·Microbiology
IS EBV-EA-D IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Electro-Nucleonics Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873925 | VIRGO(TM) MEASLES IGG ELISA | Feb 24, 1988 | Substantially Equivalent |
| K873617 | GEMSTAR II SYSTEM | Oct 19, 1987 | Substantially Equivalent |
| K873416 | MULTI-ACCESS REAGENT DISPENSER | Oct 9, 1987 | Substantially Equivalent |
| K873358 | GEMENI URIC ACID U.V. | Sep 11, 1987 | Substantially Equivalent |
| K873088 | VIRGO(TM) RUBELLA IGG ELISA | Sep 9, 1987 | Substantially Equivalent |
| K871905 | TOXOPLASMA GONDII IGG ELISA | Jul 30, 1987 | Substantially Equivalent |
| K870928 | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS | Apr 22, 1987 | Substantially Equivalent |
| K863874 | LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES | Nov 13, 1986 | Substantially Equivalent |
| K862640 | AMYLASE LTS | Sep 9, 1986 | Substantially Equivalent |
| K853372 | GEMSTAR IPA THEOPHYLLINE TEST KIT | Sep 4, 1985 | Substantially Equivalent |