Amnio-Grow TM
FDA 510(k) K892938 · Inovar Biologicals, Inc.
510(k) numberK892938
Submission
- Device name
- Amnio-Grow TM
- Applicant
- Inovar Biologicals, Inc.
Gaithersburg, MD, US - Received
- April 21, 1989
- Decision date
- May 22, 1989
- 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 |
|---|---|---|---|
| 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 |
| K883951 | Medium 199 W/Ebss (Catalog No. 200-2037)KIT · Traditional | J R Scientific | 09/30/1988SE |
Questions and answers
When was Amnio-Grow TM cleared by the FDA?
Amnio-Grow TM (K892938) received a 510(k) decision of Substantially Equivalent on May 22, 1989, 31 days after the submission was received.
What is the product code of K892938?
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.