FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTIBODY TO VARICELLA-ZOSTER VIRUS
K Number: K800787
·
Decision Jul 14, 1980
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
30
Applicant Total
41
Review Days
97
Basic Information
- Device Name
- ANTIBODY TO VARICELLA-ZOSTER VIRUS
- K Number
- K800787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7925
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- ELECTRO-NUCLEONICS LABORATORIES, INC.
- Date Received
- April 8, 1980
- Decision Date
- July 14, 1980
- Product Code
- GGW
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| GGW | Test, Time, Partial Thromboplastin | FDA class 2 | Hematology |
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Other Clearances by ELECTRO-NUCLEONICS LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |