Mem-Eagle W/Earles Salts W/Iveaa
FDA 510(k) K833163 · Sigma Chemical Co.
510(k) numberK833163
Submission
- Device name
- Mem-Eagle W/Earles Salts W/Iveaa
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- September 16, 1983
- Decision date
- October 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIT – Media And Components, Synthetic Cell And Tissue Culture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2220
- Specialty
- Hematology
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|---|---|---|---|
| K892938 | Amnio-Grow TMKIT · Traditional | Inovar Biologicals, Inc. | 05/22/1989SE |
| K890701 | Endothelial Growth Medium (Egm)KIT · Traditional | Clonetics Corp. | 02/24/1989SE |
| K890700 | Melanocyte Growth Medium (MGM)KIT · Traditional | Clonetics Corp. | 02/24/1989SE |
| K890482 | Abc, ABC-1X, Abc(Tm)KIT · Traditional | Cell Ent., Inc. | 02/10/1989SE |
| K884654 | Alphacalf SerumKIT · Traditional | Hyclone Laboratories, Inc. | 11/30/1988SE |
| K884574 | Dme & Ham's Nutrient Mixture, Prod. No. D9785KIT · Traditional | Sigma Chemical Co. | 11/22/1988SE |
| K884573 | HBSS W/O Calc Chlor/Mag Sulf/Phen Red/Sb No. H4891KIT · Traditional | Sigma Chemical Co. | 11/22/1988SE |
| K884572 | RPMI-1640 Hybri-Max, Prod. No. R5382KIT · Traditional | Sigma Chemical Co. | 11/22/1988SE |
| K883065 | Alloprep SystemKIT · Traditional | Osteotech, Inc. | 10/13/1988SE |
| K884031 | FBS, Eq., or Fetal Bovine Serum EquivalentKIT · Traditional | Regency Biotech | 10/06/1988SE |
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| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
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Questions and answers
When was Mem-Eagle W/Earles Salts W/Iveaa cleared by the FDA?
Mem-Eagle W/Earles Salts W/Iveaa (K833163) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 42 days after the submission was received.
What is the product code of K833163?
The FDA product code is KIT – Media And Components, Synthetic Cell And Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2220.