Bactigen Salmonella-Shigella Test
FDA 510(k) K870813 · Armkel, LLC
510(k) numberK870813
Submission
- Device name
- Bactigen Salmonella-Shigella Test
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- March 3, 1987
- Decision date
- April 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GRM – Antisera, All Groups, Salmonella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3550
- Specialty
- Microbiology
Other 510(k)s with product code GRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961967 | SAS Salmonella O Poly B AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961966 | SAS Salmonella O Group X Factor 47 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961964 | SAS Salmonella O Group H Factors 14,24,25 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961963 | SAS Salmonella O Group W Factor 45 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961962 | SAS Salmonella O Group V Factor 44 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961961 | SAS Salmonella H F,G,T AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961960 | SAS Salmonella H Z4, Z24 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961958 | SAS Salmonella H Z4 Complex AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961957 | SAS Salmonella H Z4, Z32 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961956 | SAS Salmonella H G,M,Q AntisermuGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K040866 | First Response One-Step Digital Pregnancy TestLCX · Traditional | 10/19/2004SE |
| K030258 | First Response Pregnancy TestLCX · Traditional | 02/25/2003SE |
| K023405 | Trojan Mint Tingle Brand Latex CondomsHIS · Abbreviated | 12/16/2002SE |
| K013433 | Trojan Passion Berry GelNUC · Traditional | 03/05/2002SE |
| K013614 | Trojan Crystal Clear LiquidNUC · Traditional | 02/01/2002SE |
| K001212 | Trojan Extra Large Latex CondomHIS · Special | 05/09/2000SE |
| K000748 | Trojan Latex Condom with Male Genital Desensitizer LubricantHIS · Special | 04/06/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | 10/27/1997SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | 10/27/1997SE |
Questions and answers
When was Bactigen Salmonella-Shigella Test cleared by the FDA?
Bactigen Salmonella-Shigella Test (K870813) received a 510(k) decision of Substantially Equivalent on April 22, 1987, 50 days after the submission was received.
What is the product code of K870813?
The FDA product code is GRM – Antisera, All Groups, Salmonella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3550.