FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALPHA-TOXIN DISCS
K Number: K821992
·
Decision Oct 18, 1982
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
243
Applicant Total
9
Review Days
103
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Basic Information
- Device Name
- ALPHA-TOXIN DISCS
- K Number
- K821992
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Microchemical Specialities, Co.
- Date Received
- July 7, 1982
- Decision Date
- October 18, 1982
- Product Code
- JTO
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | FDA class 1 | Microbiology |
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Other Clearances by Microchemical Specialities, Co.
| K Number | Device Name | ||
|---|---|---|---|
| K823198 | RAPID PRESUMPTIVE IDENT. GPA STREP | Nov 16, 1982 | Substantially Equivalent |
| K811853 | PHOLPHORYL-ASE TUBES | Jul 16, 1981 | Substantially Equivalent |
| K811852 | REDUCT-ASE TUBES | Jul 16, 1981 | Substantially Equivalent |
| K811854 | GALACTOSID-ASE TUBES | Jul 16, 1981 | Substantially Equivalent |
| K801916 | ORNITH-ASE TUBES | Aug 20, 1980 | Substantially Equivalent |
| K801915 | ENZYME-ASE I TUBES | Aug 20, 1980 | Substantially Equivalent |
| K800816 | HIPPUR-ASE TUBES | Jul 8, 1980 | Substantially Equivalent |
| K800579 | BETA-ASE TUBES | Apr 8, 1980 | Substantially Equivalent |