FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM
K Number: K833393
·
Decision Nov 3, 1983
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
366
Applicant Total
231
Review Days
36
Basic Information
- Device Name
- ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM
- K Number
- K833393
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- SIGMA CHEMICAL CO.
- Date Received
- September 28, 1983
- Decision Date
- November 3, 1983
- Product Code
- KIT
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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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