FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE
K Number: K850525
·
Decision Feb 27, 1985
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
366
Applicant Total
24
Review Days
19
Basic Information
- Device Name
- DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE
- K Number
- K850525
- 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
- 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 MEDIATECH, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K860623 | CELLGRO HEPES BUFFER SOLUTION | Mar 3, 1986 | Substantially Equivalent |
| K854567 | PENICILLIN/STREPTOMYCIN SOLUTION | Dec 6, 1985 | Substantially Equivalent |
| K852485 | CELLGRO(ISCOVE'S MEDIUM) MODIFICATION | Jul 12, 1985 | Substantially Equivalent |
| K852475 | CELLGRO WILLIAMS' MEDIUM E | Jul 12, 1985 | Substantially Equivalent |
| K852603 | MCCOY'S 5A MEDIUM - POWDERED FORM | Jul 12, 1985 | Substantially Equivalent |
| K852602 | MCCOY'S 5A MEDIUM-LIQUID FORM | 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 |
| K850513 | RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640 | Feb 27, 1985 | Substantially Equivalent |
| K850520 | NEAA-NON-ESSENTIAL AMINO ACIDS | Feb 27, 1985 | Substantially Equivalent |