Sas(Tm) QC Antigens for Salmonella Antisera
FDA 510(k) K945839 · Sa Scientific, Inc.
510(k) numberK945839
Submission
- Device name
- Sas(Tm) QC Antigens for Salmonella Antisera
- Applicant
- Sa Scientific, Inc.
San Antonio, TX, US - Received
- November 30, 1994
- Decision date
- March 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| K820996 | Salmonella & Shigella Grouping SeraGRL · Traditional | Fisher Scientific Co., LLC | 05/03/1982SE |
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| K041439 | SAS Influenza B TestPSZ · Traditional | 07/22/2004SE |
| K030628 | SAS RSV Control KitJJX · Traditional | 03/17/2003SE |
| K022845 | SAS RSV TestGQG · Traditional | 01/29/2003SE |
| K022683 | SAS Blood/Serum/Urine/Urine HCGJHI · Traditional | 12/16/2002SE |
| K023270 | SAS StrepalertGTY · Traditional | 10/17/2002SE |
Questions and answers
When was Sas(Tm) QC Antigens for Salmonella Antisera cleared by the FDA?
Sas(Tm) QC Antigens for Salmonella Antisera (K945839) received a 510(k) decision of Substantially Equivalent on March 7, 1995, 97 days after the submission was received.
What is the product code of K945839?
The FDA product code is GRL – Antigens, All Groups, Salmonella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3550.