Seroiden Strepto Kit 'Eiken'
FDA 510(k) K861098 · Syn-Kit, Inc.
510(k) numberK861098
Submission
- Device name
- Seroiden Strepto Kit 'Eiken'
- Applicant
- Syn-Kit, Inc.
Chatsworth, CA, US - Received
- March 24, 1986
- Decision date
- August 12, 1986
- 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 |
|---|---|---|
| K861631 | Slide Culture U 'Eiken'JXA · Traditional | 06/10/1986SE |
| K854819 | CPR Slide EikenDCN · Traditional | 02/26/1986SE |
| K854820 | Ra 80 EikenDHR · Traditional | 01/17/1986SE |
| K853276 | Aso Slide EikenGTQ · Traditional | 08/20/1985SE |
| K843760 | Uropaper Eiken GJIL · Traditional | 12/18/1984SE |
| K843759 | Uropaper Eiken HagJIL · Traditional | 12/18/1984SE |
| K843758 | Uropaper Eiken GKJIL · Traditional | 12/18/1984SE |
| K843757 | Uropaper Eiken AGJIL · Traditional | 12/18/1984SE |
| K843756 | Uropaper Eiken 5JIL · Traditional | 12/18/1984SE |
| K843755 | Uropaper Eiken 6BJIL · Traditional | 12/18/1984SE |
Questions and answers
When was Seroiden Strepto Kit 'Eiken' cleared by the FDA?
Seroiden Strepto Kit 'Eiken' (K861098) received a 510(k) decision of Substantially Equivalent on August 12, 1986, 141 days after the submission was received.
What is the product code of K861098?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.