Cards(Tm) Strep a Catalog No. CR-7545
FDA 510(k) K863647 · Pacific Biotech, Inc.
510(k) numberK863647
Submission
- Device name
- Cards(Tm) Strep a Catalog No. CR-7545
- Applicant
- Pacific Biotech, Inc.
San Diego, CA, US - Received
- September 18, 1986
- Decision date
- November 26, 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 |
|---|---|---|
| K924461 | Strep a Negative ControlGTZ · Traditional | 12/02/1993SE |
| K902510 | Cards O.S. MonoKTN · Traditional | 07/16/1990SE |
| K896482 | Perfect(Tm) One Step Early Pregnancy Test KitLCX · Traditional | 03/06/1990SE |
| K896221 | Cards O.S.(Tm) Strep aGTZ · Traditional | 12/13/1989SE |
| K895390 | Cards O.S. (TM) Hcg-UrineJHI · Traditional | 11/13/1989SE |
| K891770 | HCG Irma IIJHI · Traditional | 05/24/1989SE |
| K884616 | Firstday Early Pregnancy Testing Kit IIJHI · Traditional | 01/13/1989SE |
| K883742 | Modified TSH Irma KitJLW · Traditional | 01/03/1989SE |
| K884007 | Cards(Tm) MonoKTN · Traditional | 11/18/1988SE |
| K882895 | Modified Beta Quik Stat Eia KitDHA · Traditional | 10/12/1988SE |
Questions and answers
When was Cards(Tm) Strep a Catalog No. CR-7545 cleared by the FDA?
Cards(Tm) Strep a Catalog No. CR-7545 (K863647) received a 510(k) decision of Substantially Equivalent on November 26, 1986, 69 days after the submission was received.
What is the product code of K863647?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.