FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA
K Number: K850511
·
Decision Feb 27, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
24
Review Days
19
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Basic Information
- Device Name
- EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA
- K Number
- K850511
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Mediatech, Inc.
- Date Received
- February 8, 1985
- Decision Date
- February 27, 1985
- Product Code
- KIT
- 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | FDA class 1 | Hematology |
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|---|---|---|---|
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| K852475 | CELLGRO WILLIAMS' MEDIUM E | Jul 12, 1985 | Substantially Equivalent |
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| K850525 | DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE | Feb 27, 1985 | Substantially Equivalent |
| K850517 | MED. 199 W/EARLE'S SALTS-MEDIUM 199 W/EARLES SALTS | Feb 27, 1985 | Substantially Equivalent |