Salmonella & Shigella Grouping Sera
FDA 510(k) K820996 · Fisher Scientific Co., LLC
510(k) numberK820996
Submission
- Device name
- Salmonella & Shigella Grouping Sera
- Applicant
- Fisher Scientific Co., LLC
Mchenry, IL, US - Received
- April 9, 1982
- Decision date
- May 3, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GRL – Antigens, All Groups, Salmonella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3550
- Specialty
- Microbiology
Other 510(k)s with product code GRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945839 | Sas(Tm) QC Antigens for Salmonella AntiseraGRL · Traditional | Sa Scientific, Inc. | 03/07/1995SE |
More from Sa Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K930415 | Microhematocrit RotorGKG · Traditional | 03/23/1993SE |
| K915825 | Marathon 6K General-Purpose CentrifugeGKF · Traditional | 03/11/1992SE |
| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | 01/08/1992SE |
| K890534 | Modified Uriqual(Tm) Urinalysis Control Level 1JJW · Traditional | 03/08/1989SE |
| K881275 | Uriqual(Tm) Urinalysis Controls (Human) I & IIJJY · Traditional | 05/16/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
| K871058 | Serachem Liquid Spinal Fluid Control (Human)JJY · Traditional | 04/06/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | 07/10/1986SE |
Questions and answers
When was Salmonella & Shigella Grouping Sera cleared by the FDA?
Salmonella & Shigella Grouping Sera (K820996) received a 510(k) decision of Substantially Equivalent on May 3, 1982, 24 days after the submission was received.
What is the product code of K820996?
The FDA product code is GRL – Antigens, All Groups, Salmonella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3550.