FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CELLGRO HEPES BUFFER SOLUTION
K Number: K860623
·
Decision Mar 3, 1986
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
24
Review Days
12
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Basic Information
- Device Name
- CELLGRO HEPES BUFFER SOLUTION
- K Number
- K860623
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Mediatech, Inc.
- Date Received
- February 19, 1986
- Decision Date
- March 3, 1986
- 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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Other Clearances by Mediatech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854567 | PENICILLIN/STREPTOMYCIN SOLUTION | Dec 6, 1985 | Substantially Equivalent |
| K852602 | MCCOY'S 5A MEDIUM-LIQUID FORM | Jul 12, 1985 | Substantially Equivalent |
| K852603 | MCCOY'S 5A MEDIUM - POWDERED FORM | Jul 12, 1985 | Substantially Equivalent |
| K852485 | CELLGRO(ISCOVE'S MEDIUM) MODIFICATION | Jul 12, 1985 | Substantially Equivalent |
| K852475 | CELLGRO WILLIAMS' MEDIUM E | Jul 12, 1985 | Substantially Equivalent |
| K852288 | CELLGRO | Jun 4, 1985 | Substantially Equivalent |
| K850510 | EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN | Mar 4, 1985 | Substantially Equivalent |
| 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 |
| K850523 | EBSS-EARLE'S BALANCE SALT SOLUTION | Feb 27, 1985 | Substantially Equivalent |