FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LPIA-FERRITIN ASSAY
K Number: K924186
·
Decision Dec 23, 1992
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
18
Review Days
125
Basic Information
- Device Name
- LPIA-FERRITIN ASSAY
- K Number
- K924186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5425
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SERADYN, INC.
- Date Received
- August 20, 1992
- Decision Date
- December 23, 1992
- Product Code
- DEF
- 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 |
|---|---|---|---|
| DEF | Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control | FDA class 1 | Immunology |
Other Clearances by SERADYN, INC.
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|---|---|---|---|
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| K952544 | COLORSLIDER RUBELLA | Jan 17, 1996 | Substantially Equivalent |
| K942991 | QMS THEOPHYLLINE CS | Sep 9, 1994 | Substantially Equivalent |
| K940374 | QMS CARBAMAZEPINE ASSAY | Jun 2, 1994 | Substantially Equivalent |
| K940376 | QMS GENTAMICIN ASSAY | Jun 2, 1994 | Substantially Equivalent |
| K936208 | VALPROIC ACID | Mar 11, 1994 | Substantially Equivalent |
| K934388 | QMS PHENOBARBITAL | Feb 25, 1994 | Substantially Equivalent |
| K925326 | ELECTROPHORESIS CONTROL LEVEL 1 | Mar 26, 1993 | Substantially Equivalent |
| K913562 | QMS - DIGOXIN | Aug 30, 1991 | Substantially Equivalent |