FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EARLE'S MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED
K Number: K850223
·
Decision Mar 7, 1985
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
366
Applicant Total
47
Review Days
44
Basic Information
- Device Name
- EARLE'S MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED
- K Number
- K850223
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- HAZLETON RESEARCH PRODUCTS, INC.
- Date Received
- January 22, 1985
- Decision Date
- March 7, 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 HAZLETON RESEARCH PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K861997 | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | Jun 10, 1986 | Substantially Equivalent |
| K861996 | DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM | Jun 9, 1986 | Substantially Equivalent |
| K861875 | RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER | May 29, 1986 | Substantially Equivalent |
| K861872 | ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM | May 29, 1986 | Substantially Equivalent |
| K861869 | GENTAMICIN-50MG/ML | May 29, 1986 | Substantially Equivalent |
| K861886 | DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM | May 29, 1986 | Substantially Equivalent |
| K861871 | NCTC 109 MEDIUM | May 29, 1986 | Substantially Equivalent |
| K861874 | MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER | May 29, 1986 | Substantially Equivalent |
| K861885 | WILLIAMS MEDIUM E POWDER | May 29, 1986 | Substantially Equivalent |
| K861867 | MEM ALPHA EAGLE MEDIUM | May 29, 1986 | Substantially Equivalent |