FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TISSUE CULTURE MEDIA W/HEPES BUFFER
K Number: K770764
·
Decision Jul 21, 1977
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
8
Review Days
85
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Basic Information
- Device Name
- TISSUE CULTURE MEDIA W/HEPES BUFFER
- K Number
- K770764
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Microbiological Assoc.
- Date Received
- April 27, 1977
- Decision Date
- July 21, 1977
- Product Code
- KIT
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | FDA class 1 | Hematology |
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Other Clearances by Microbiological Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K792133 | RUBELISA TEST KIT | Jan 11, 1980 | Substantially Equivalent |
| K791397 | HERPES EIA TEST KIT | Sep 24, 1979 | Substantially Equivalent |
| K781549 | TOXELISA TEST KIT | Dec 7, 1978 | Substantially Equivalent |
| K780996 | RUBELISA TEST KIT | Nov 22, 1978 | Substantially Equivalent |
| K781392 | CYTOMEGILISH TEST KIT | Oct 24, 1978 | Substantially Equivalent |
| K781143 | IMMUNOFLUORESCENCE TEST KIT | Aug 14, 1978 | Substantially Equivalent |
| K770687 | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | Jun 14, 1977 | Substantially Equivalent |