Lyophilized Microorganisms
FDA 510(k) K831653 · Austin Biological Laboratories
510(k) numberK831653
Submission
- Device name
- Lyophilized Microorganisms
- Applicant
- Austin Biological Laboratories
Mchenry, IL, US - Received
- May 23, 1983
- Decision date
- July 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTR – Kit, Quality Control For Culture Media
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2480
- Specialty
- Microbiology
Other 510(k)s with product code JTR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871121 | Protect T.M.JTR · Traditional | Pro-Lab, Inc. | 04/14/1987SE |
| K862914 | Fekal Check Parasitology Control SlideJTR · Traditional | Trend Scientific, Inc. | 09/16/1986SE |
| K861022 | Kwik Stik(Tm) Lyfo(Tm) Disk MicroorganismsJTR · Traditional | Micro-Bio-Logics | 04/04/1986SE |
| K855198 | Indi Kwik (TM) Co/Two KitJTR · Traditional | Micro-Bio-Logics | 01/14/1986SE |
| K842579 | B.E.C. Growth Chek Microbial SuspensionsJTR · Traditional | Biological & Environmental Control Laboratories | 07/27/1984SE |
| K842129 | Lyfo-Disk MicroorganismsJTR · Traditional | Micro-Bio-Logics | 07/03/1984SE |
| K830133 | Q-Check Culti-LoopsJTR · Traditional | Lab Ability, Inc. | 02/09/1983SE |
| K822954 | Microtech Bacterial ControlsJTR · Traditional | Universal Micro Reference Laboratory | 11/16/1982SE |
| K821660 | Bio-Check Gram Stain ControlJTR · Traditional | American Scientific Products | 06/25/1982SE |
| K820064 | SusceptrolJTR · Traditional | American Type Culture Collection | 01/28/1982SE |
More from American Type Culture Collection
| 510(k) | Device | Decision |
|---|---|---|
| K880511 | Xact NeisseriaJSX · Traditional | 08/25/1988SE |
| K874727 | Precept(Tm) CiprofloxacinJWY · Traditional | 02/18/1988SE |
| K870769 | Austin Nonfermenter KitJSW · Traditional | 04/03/1987SE |
| K864069 | Precept (TM) Ticarcillin/Clavulanic AcidJWY · Traditional | 11/13/1986SE |
| K862560 | Precept CeftizoximeJWY · Traditional | 07/11/1986SE |
| K862446 | Precept CeftazidimeJWY · Traditional | 07/11/1986SE |
| K860195 | Precept Trimethoprim/SulfamethoxazoleJWY · Traditional | 02/20/1986SE |
| K860194 | Austin Enteric SystemJSE · Traditional | 02/20/1986SE |
| K854577 | Precept Amoxicillin/Clavvlanic Acid (Augmentin)JWY · Traditional | 02/05/1986SE |
| K853772 | Precept MethicillinLTW · Traditional | 09/16/1985SE |
Questions and answers
When was Lyophilized Microorganisms cleared by the FDA?
Lyophilized Microorganisms (K831653) received a 510(k) decision of Substantially Equivalent on July 28, 1983, 66 days after the submission was received.
What is the product code of K831653?
The FDA product code is JTR – Kit, Quality Control For Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2480.