FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEMENI IGG ASSAY
K Number: K800451
·
Decision Apr 24, 1980
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
75
Applicant Total
41
Review Days
55
Basic Information
- Device Name
- GEMENI IGG ASSAY
- K Number
- K800451
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- ELECTRO-NUCLEONICS LABORATORIES, INC.
- Date Received
- February 29, 1980
- Decision Date
- April 24, 1980
- Product Code
- DEW
- 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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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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 |