Cell Culture Reagents
FDA 510(k) K812531 · M.A. Bioproducts
510(k) numberK812531
Submission
- Device name
- Cell Culture Reagents
- Applicant
- M.A. Bioproducts
Mchenry, IL, US - Received
- September 2, 1981
- Decision date
- October 23, 1981
- 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
Other 510(k)s with product code KIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Regency Biotech
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|---|---|---|
| K822883 | Herpelisa KitLGC · Traditional | 07/26/1983SE |
| K823804 | Mycoplasmelisa Test KitLJZ · Traditional | 05/25/1983SE |
| K830045 | Mumpselisa Test KitLJY · Traditional | 05/13/1983SE |
| K830615 | Cytomegelisa StatLFZ · Traditional | 05/09/1983SE |
| K823805 | Varicelisa Test KitLFY · Traditional | 05/05/1983SE |
| K821967 | Chlamydelisa Test KitLJC · Traditional | 08/03/1982SE |
| K821762 | Measelisa Test KitLJB · Traditional | 07/30/1982SE |
| K813221 | Toxoelisa Test KitLGD · Traditional | 01/26/1982SE |
| K812123 | Cytomegelisa Test Kit · Traditional | 09/23/1981SE |
| K802508 | Rubelisa Igm Test KitGOL · Traditional | 12/18/1980SE |
Questions and answers
When was Cell Culture Reagents cleared by the FDA?
Cell Culture Reagents (K812531) received a 510(k) decision of Substantially Equivalent on October 23, 1981, 51 days after the submission was received.
What is the product code of K812531?
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.