FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROBIOLOGY CULTURE MEDIA, C.L.E.D.
K Number: K801817
·
Decision Aug 27, 1980
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
7
Review Days
27
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Basic Information
- Device Name
- MICROBIOLOGY CULTURE MEDIA, C.L.E.D.
- K Number
- K801817
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Radiation Technology, Inc.
- Date Received
- July 31, 1980
- Decision Date
- August 27, 1980
- 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 Radiation Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910648 | THERAPY CHAIR SYSTEM | Jul 22, 1991 | Substantially Equivalent |
| K802892 | CULTURE MEDIA FOR IN VITRO DIAG. USE | Dec 11, 1980 | Substantially Equivalent |
| K801943 | BRAIN HEART INFUSION MICROBIOLOGICAL | Sep 9, 1980 | Substantially Equivalent |
| K801772 | MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG | Aug 20, 1980 | Substantially Equivalent |
| K801901 | MUELLER HINTON AGAR | Aug 20, 1980 | Substantially Equivalent |
| K801847 | TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA | Aug 13, 1980 | Substantially Equivalent |