FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TEST SYSTEM TISSUE CELL CULTURE SLIDE
K Number: K781516
·
Decision Sep 27, 1978
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
0
Applicant Total
135
Review Days
27
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Basic Information
- Device Name
- TEST SYSTEM TISSUE CELL CULTURE SLIDE
- K Number
- K781516
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Zeus Scientific, Inc.
- Date Received
- August 31, 1978
- Decision Date
- September 27, 1978
- Product Code
- KIY
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KIY | Chamber, Slide Culture | FDA class 1 | Hematology |
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