Sero-Stat Streptococcus Test
FDA 510(k) K790492 · Scott Laboratories, Inc.
510(k) numberK790492
Submission
- Device name
- Sero-Stat Streptococcus Test
- Applicant
- Scott Laboratories, Inc.
Mchenry, IL, US - Received
- March 13, 1979
- Decision date
- May 1, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTZ – Antisera, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code GTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012521 | Binax Now Streptococcus Pneumoniae TestGTZ · Traditional | Binax, Inc. | 11/30/2001SE |
| K011709 | Uni-Gold Strep a Test KitGTZ · Traditional | Trinity Biotech, Plc | 11/08/2001SE |
| K010523 | Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen TestGTZ · Special | Binax, Inc. | 03/15/2001SE |
| K991726 | Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test KIT),(12 Test Kit)…GTZ · Traditional | Binax, Inc. | 08/27/1999SE |
| K971522 | Abbott Testpack Plus Strep a with on Board Controls (Obc) IIGTZ · Traditional | Abbott Laboratories | 03/03/1998SE |
| K962060 | Strep a Oia MaxGTZ · Traditional | Biostar, Inc. | 07/23/1997SE |
| K962296 | Streptolex-StatGTZ · Traditional | Unipath , Ltd. | 12/16/1996SE |
| K961423 | Osom Strep a TestGTZ · Traditional | Wyntek Diagnostics, Inc. | 10/11/1996SE |
| K962146 | Excel Onestep Group a Strep Antigen Module Test KitGTZ · Traditional | Excel Scientific, Inc. | 10/07/1996SE |
| K955108 | Cards Q.S. Strep aGTZ · Traditional | Quidel Corp. | 04/15/1996SE |
More from Quidel Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K880694 | B. Cat ConfirmJTO · Traditional | 06/16/1988SE |
| K874933 | Mug-Indole DiscJTO · Traditional | 01/05/1988SE |
| K874662 | Myco-Fluor Reagent a & BJTS · Traditional | 11/25/1987SE |
| K873509 | Identicult-BlJTO · Traditional | 10/15/1987SE |
| K871238 | AnabagKZJ · Traditional | 04/03/1987SE |
| K863025 | Sero-Stat R II Staphylococcus TestLHT · Traditional | 09/15/1986SE |
| K852869 | Selecticult-ChlamydiaLKH · Traditional | 09/19/1985SE |
| K852832 | Identicult-NeisseriaJTO · Traditional | 07/19/1985SE |
| K852666 | Identicult-AeJTO · Traditional | 07/15/1985SE |
| K841680 | Scott Selecticult-Hsv Isolation &GQL · Traditional | 10/30/1984SE |
Questions and answers
When was Sero-Stat Streptococcus Test cleared by the FDA?
Sero-Stat Streptococcus Test (K790492) received a 510(k) decision of Substantially Equivalent on May 1, 1979, 49 days after the submission was received.
What is the product code of K790492?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.