FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT
K Number: K800398
·
Decision Mar 12, 1980
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
12
Review Days
15
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Basic Information
- Device Name
- PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT
- K Number
- K800398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostica, Inc.
- Date Received
- February 26, 1980
- Decision Date
- March 12, 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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IGG
FDA 510(k)
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·Immunology
Other Clearances by Diagnostica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002756 | EASE-A-CULT | Feb 23, 2001 | Substantially Equivalent |
| K823348 | H. INFLUENZA B ANTISERA FOR CIE | Dec 28, 1982 | Substantially Equivalent |
| K812434 | DIAGNOSTIC KITS & KIT COMPONENTS | Sep 23, 1981 | Substantially Equivalent |
| K791283 | ANTI-HUMAN LAMBDA SERUM | Nov 27, 1979 | Substantially Equivalent |
| K791281 | ANTI-HUMAN IGG SERUM | Nov 27, 1979 | Substantially Equivalent |
| K791284 | ANTI-HUMAN KAPPA SERUM | Nov 27, 1979 | Substantially Equivalent |
| K791285 | ANTI-HUMAN GLOBULINS | Oct 17, 1979 | Substantially Equivalent |
| K791282 | ANTI-HUMAN SERUM | Oct 17, 1979 | Substantially Equivalent |
| K790672 | ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU | May 31, 1979 | Substantially Equivalent |
| K790671 | DERMATOPHYTIN O | May 31, 1979 | Substantially Equivalent |