Immunocard Strep a Test
FDA 510(k) K896109 · Disease Detection International, Inc.
510(k) numberK896109
Submission
- Device name
- Immunocard Strep a Test
- Applicant
- Disease Detection International, Inc.
Irvine, CA, US - Received
- October 23, 1989
- Decision date
- November 29, 1989
- 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 |
|---|---|---|
| K943252 | Pro-Step LH Ovulation Prediction TestCEP · Traditional | 10/25/1994SE |
| K925303 | Pro-Step PT HCGJHI · Traditional | 06/15/1993SE |
| K925125 | Pro-Step HCGJHI · Traditional | 01/13/1993SE |
| K911826 | Immunocard HCG One Step (I-S) Test KitJHI · Traditional | 07/19/1991SE |
| K902571 | Modification of Serocard Rubella Igg TestLFX · Traditional | 09/05/1990SE |
| K903070 | Serocard HSV Igg Antibody Test KitLGC · Traditional | 08/09/1990SE |
| K895912 | Immunocard HCG Ii-S Test KitJHI · Traditional | 12/01/1989SE |
| K884249 | Modified Ddi Serocard Toxoplasma Igg Test KitLGD · Traditional | 04/10/1989SE |
| K884248 | Modified Ddi Serocard CMV Igg Test KitLFZ · Traditional | 04/10/1989SE |
| K884247 | Modified Ddi Serocard Rubella Igg Test KitLFX · Traditional | 04/10/1989SE |
Questions and answers
When was Immunocard Strep a Test cleared by the FDA?
Immunocard Strep a Test (K896109) received a 510(k) decision of Substantially Equivalent on November 29, 1989, 37 days after the submission was received.
What is the product code of K896109?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.