Kwi (TM) G-Co/Two
FDA 510(k) K855172 · Micro-Bio-Logics
510(k) numberK855172
Submission
- Device name
- Kwi (TM) G-Co/Two
- Applicant
- Micro-Bio-Logics
St. Cloud, MN, US - Received
- December 26, 1985
- Decision date
- February 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSK – Supplement, Culture Media
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2450
- Specialty
- Microbiology
Other 510(k)s with product code JSK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881949 | Ats Nac-Pac SetJSK · Traditional | Alpha-Tec Systems, Inc. | 05/25/1988SE |
| K881879 | Ats M/15 Phosphate Buffer, Product #034-42JSK · Traditional | Alpha-Tec Systems, Inc. | 05/13/1988SE |
| K881566 | Hemoglobin PowderJSK · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K861997 | Penicillin-Streptomycin-Fungizone MixtureJSK · Traditional | Hazleton Research Products, Inc. | 06/10/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | Flow Laboratories, Inc. | 05/20/1986SE |
| K853546 | Abbott Cation Supplement SolutionJSK · Traditional | Abbott Laboratories | 09/06/1985SE |
| K850302 | Suplex & Suplex DiluentJSK · Traditional | Pro-Lab, Inc. | 03/22/1985SE |
| K850738 | Supplement for Culture MediumJSK · Traditional | Roseville Medical Laboratoriesu | 03/20/1985SE |
More from Roseville Medical Laboratoriesu
| 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 |
| 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 |
| K842129 | Lyfo-Disk MicroorganismsJTR · Traditional | 07/03/1984SE |
Questions and answers
When was Kwi (TM) G-Co/Two cleared by the FDA?
Kwi (TM) G-Co/Two (K855172) received a 510(k) decision of Substantially Equivalent on February 20, 1986, 56 days after the submission was received.
What is the product code of K855172?
The FDA product code is JSK – Supplement, Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2450.