FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G
K Number: K772077
·
Decision Feb 3, 1978
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
11
Review Days
92
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Basic Information
- Device Name
- RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G
- K Number
- K772077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Gelman Instrument Co.
- Date Received
- November 3, 1977
- Decision Date
- February 3, 1978
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DEW), ordered by most recent decision date.
TINA-QUANT IGG GEN.2
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ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
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SPIFE IFE CALIBRATOR AND CONTROL KIT
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WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
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K-ASSAY IGG
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IGG
FDA 510(k)
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Other Clearances by Gelman Instrument Co.
| K Number | Device Name | ||
|---|---|---|---|
| K772075 | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT | Feb 3, 1978 | Substantially Equivalent |
| K772076 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. | Feb 3, 1978 | Substantially Equivalent |
| K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT | Feb 3, 1978 | Substantially Equivalent |
| K772074 | RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN | Feb 3, 1978 | Substantially Equivalent |
| K772079 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M | Feb 3, 1978 | Substantially Equivalent |
| K772073 | RADIAL IMMUNODIFFUSION KIT-COMP. 3 | Feb 3, 1978 | Substantially Equivalent |
| K772078 | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN | Feb 3, 1978 | Substantially Equivalent |
| K772325 | DENSITOMETER 18, COMPUTING, AUTO. | Jan 12, 1978 | Substantially Equivalent |
| K771812 | LIPPOPROTEIN ELECTROPHORESIS REAGENT SET | Oct 18, 1977 | Substantially Equivalent |
| K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | Jan 31, 1977 | Substantially Equivalent |