FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG
K Number: K801772
·
Decision Aug 20, 1980
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
14
Applicant Total
7
Review Days
23
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Basic Information
- Device Name
- MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG
- K Number
- K801772
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2310
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Radiation Technology, Inc.
- Date Received
- July 28, 1980
- Decision Date
- August 20, 1980
- Product Code
- JJH
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJH | Clinical Sample Concentrator | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJH), ordered by most recent decision date.
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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 |
| K801817 | MICROBIOLOGY CULTURE MEDIA, C.L.E.D. | Aug 27, 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 |