Bio-Check Gram Stain Control
FDA 510(k) K821660 · American Scientific Products
510(k) numberK821660
Submission
- Device name
- Bio-Check Gram Stain Control
- Applicant
- American Scientific Products
Mchenry, IL, US - Received
- June 4, 1982
- Decision date
- June 25, 1982
- 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 |
| 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 |
| K820064 | SusceptrolJTR · Traditional | American Type Culture Collection | 01/28/1982SE |
More from American Type Culture Collection
| 510(k) | Device | Decision |
|---|---|---|
| K864824 | Infectious Tissue Kit · Traditional | 12/24/1986SE |
| K844042 | Blood Dilution VialGKL · Traditional | 10/23/1984SE |
| K831634 | Glucose Reagent B6360-11CGA · Traditional | 07/19/1983SE |
| K831626 | Urea Nitrogen-Bun-Reagents B6370-11ACDQ · Traditional | 07/07/1983SE |
| K831625 | Urea Nitrogen-Bun-Reagents B6360-12CDQ · Traditional | 07/07/1983SE |
| K831628 | Creatinine Reagents B6370-13CGX · Traditional | 07/06/1983SE |
| K831627 | Creatinine Reagents B6360-10CGX · Traditional | 07/06/1983SE |
| K831624 | Glucose Reagent KITS-B6370-10ACGA · Traditional | 07/06/1983SE |
| K831571 | RotorJJG · Traditional | 06/30/1983SE |
| K831569 | Reagent CupsJJG · Traditional | 06/30/1983SE |
Questions and answers
When was Bio-Check Gram Stain Control cleared by the FDA?
Bio-Check Gram Stain Control (K821660) received a 510(k) decision of Substantially Equivalent on June 25, 1982, 21 days after the submission was received.
What is the product code of K821660?
The FDA product code is JTR – Kit, Quality Control For Culture Media, a Class I (low risk) device regulated under 21 CFR 866.2480.