Dipstick Salmonella
FDA 510(k) K910438 · Ampcor, Inc.
510(k) numberK910438
Submission
- Device name
- Dipstick Salmonella
- Applicant
- Ampcor, Inc.
Bridgeport, NJ, US - Received
- January 31, 1991
- Decision date
- September 13, 1991
- 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 |
More from Sa Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922297 | Infectious Mononucleosis Qik-Dot Im Dry Card TestKTN · Traditional | 07/14/1992SE |
| K922296 | Imfectious Mononucleosis Im Liquid Card TestKTN · Traditional | 07/14/1992SE |
| K893873 | Single and Dual Band Dipstick HCG TestDHA · Traditional | 08/21/1989SE |
| K890048 | Quik-Dot ToxoplasmosisLLA · Traditional | 06/09/1989SE |
| K892146 | C Reactive Protein LiquidDCK · Traditional | 04/14/1989SE |
| K892119 | Quik-Dot C Reactive ProteinDCK · Traditional | 04/14/1989SE |
| K890025 | Quik-Dot Antistreptolysin-OGTQ · Traditional | 01/31/1989SE |
| K884750 | Group a Strep, Beta-StrepGTZ · Traditional | 12/22/1988SE |
| K880163 | Pregnancy (HCG) Card & Liquid TestJHJ · Traditional | 05/17/1988SE |
| K880478 | Pregnancy Beta-Hcg Card & Liquid TestJHJ · Traditional | 04/28/1988SE |
Questions and answers
When was Dipstick Salmonella cleared by the FDA?
Dipstick Salmonella (K910438) received a 510(k) decision of Substantially Equivalent on September 13, 1991, 225 days after the submission was received.
What is the product code of K910438?
The FDA product code is GRM – Antisera, All Groups, Salmonella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3550.