FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NUTRIENT MIXTURE F-12 (HAM) NO. 200-2071
K Number: K882993
·
Decision Aug 4, 1988
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
132
Review Days
16
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Basic Information
- Device Name
- NUTRIENT MIXTURE F-12 (HAM) NO. 200-2071
- K Number
- K882993
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- J R Scientific
- Date Received
- July 19, 1988
- Decision Date
- August 4, 1988
- 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 J R Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K883951 | MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) | Sep 30, 1988 | Substantially Equivalent |
| K883626 | EX-CELL 301, CATALOG NO. 210-3577 | Sep 7, 1988 | Substantially Equivalent |
| K883623 | EX-CELL 300TM, CATALOG NO. 200-3600 | Sep 7, 1988 | Substantially Equivalent |
| K883627 | MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 | Sep 7, 1988 | Substantially Equivalent |
| K883632 | EX-CELL 300TM, CATALOG NO. 210-3575 | Sep 7, 1988 | Substantially Equivalent |
| K883628 | MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051 | Sep 7, 1988 | Substantially Equivalent |
| K883630 | RPMI-1640 MEDIUM, CATALOG NO. 210-3525 | Sep 7, 1988 | Substantially Equivalent |
| K883624 | EX-CELL 300TM, CATALOG NO. 200-3601 | Sep 7, 1988 | Substantially Equivalent |
| K883625 | EX-CELL 301, CATALOG NO. 200-3651 | Sep 7, 1988 | Substantially Equivalent |
| K883631 | EX-CELL 300TM, CATALOG # 210-3579 | Sep 7, 1988 | Substantially Equivalent |