Tandem Icon Strep a Immunoenzymetric Assay Kit
FDA 510(k) K860778 · Hybritech, Inc.
510(k) numberK860778
Submission
- Device name
- Tandem Icon Strep a Immunoenzymetric Assay Kit
- Applicant
- Hybritech, Inc.
San Diego, CA, US - Received
- March 3, 1986
- Decision date
- April 4, 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 |
|---|---|---|
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | 09/11/1997SE |
| K961573 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 08/19/1996SE |
| K930810 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 01/11/1994SE |
| K922754 | Tandem-E Ige II Calibration Verification SetJJX · Traditional | 02/17/1993SE |
| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | 07/30/1992SE |
| K921252 | Tandem-E Ferritin Calibration Verification ConrolJJX · Traditional | 07/17/1992SE |
| K920556 | Tandem-E HCG Calibration Verification Control SetJJX · Traditional | 07/17/1992SE |
| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 06/09/1992SE |
| K912439 | Tandem-E TSH Calibration Verification Control SetJJX · Traditional | 08/28/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | 07/24/1991SE |
Questions and answers
When was Tandem Icon Strep a Immunoenzymetric Assay Kit cleared by the FDA?
Tandem Icon Strep a Immunoenzymetric Assay Kit (K860778) received a 510(k) decision of Substantially Equivalent on April 4, 1986, 32 days after the submission was received.
What is the product code of K860778?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.