FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REDUCT-ASE TUBES
K Number: K811852
·
Decision Jul 16, 1981
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
9
Review Days
15
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Basic Information
- Device Name
- REDUCT-ASE TUBES
- K Number
- K811852
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Microchemical Specialities, Co.
- Date Received
- July 1, 1981
- Decision Date
- July 16, 1981
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | 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 |
| K821992 | ALPHA-TOXIN DISCS | Oct 18, 1982 | Substantially Equivalent |
| K811853 | PHOLPHORYL-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 |