Lyfo-Disk Microorganisms
FDA 510(k) K842129 · Micro-Bio-Logics
510(k) numberK842129
Submission
- Device name
- Lyfo-Disk Microorganisms
- Applicant
- Micro-Bio-Logics
Mchenry, IL, US - Received
- May 29, 1984
- Decision date
- July 3, 1984
- 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 |
| K831653 | Lyophilized MicroorganismsJTR · Traditional | Austin Biological Laboratories | 07/28/1983SE |
| 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 |
|---|---|---|
| K870731 | Lyfo Kwik(Tm) Rus KitJXA · Traditional | 06/17/1987SE |
| K861312 | Lyfo-Kwik (TM) Coagulase PlasmaJTL · Traditional | 04/18/1986SE |
| K861022 | Kwik Stik(Tm) Lyfo(Tm) Disk MicroorganismsJTR · Traditional | 04/04/1986SE |
| K855172 | Kwi (TM) G-Co/TwoJSK · Traditional | 02/20/1986SE |
| K855198 | Indi Kwik (TM) Co/Two KitJTR · Traditional | 01/14/1986SE |
| K852998 | Neisseria - Kwik PlusJSX · Traditional | 07/23/1985SE |
| K851978 | Lyfo-Kwik Omi KitJSS · Traditional | 06/04/1985SE |
| K844014 | Ono/Co-Two (TM) SystemsJTY · Traditional | 10/31/1984SE |
Questions and answers
When was Lyfo-Disk Microorganisms cleared by the FDA?
Lyfo-Disk Microorganisms (K842129) received a 510(k) decision of Substantially Equivalent on July 3, 1984, 35 days after the submission was received.
What is the product code of K842129?
The FDA product code is JTR – Kit, Quality Control For Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2480.