Group a Strep, Beta-Strep
FDA 510(k) K884750 · Ampcor, Inc.
510(k) numberK884750
Submission
- Device name
- Group a Strep, Beta-Strep
- Applicant
- Ampcor, Inc.
Bridgeport, NJ, US - Received
- November 14, 1988
- Decision date
- December 22, 1988
- 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 |
|---|---|---|
| K922297 | Infectious Mononucleosis Qik-Dot Im Dry Card TestKTN · Traditional | 07/14/1992SE |
| K922296 | Imfectious Mononucleosis Im Liquid Card TestKTN · Traditional | 07/14/1992SE |
| K910438 | Dipstick SalmonellaGRM · Traditional | 09/13/1991SE |
| K893873 | Single and Dual Band Dipstick HCG TestDHA · Traditional | 08/21/1989SE |
| K890048 | Quik-Dot ToxoplasmosisLLA · Traditional | 06/09/1989SE |
| K892146 | C Reactive Protein LiquidDCK · Traditional | 04/14/1989SE |
| K892119 | Quik-Dot C Reactive ProteinDCK · Traditional | 04/14/1989SE |
| K890025 | Quik-Dot Antistreptolysin-OGTQ · Traditional | 01/31/1989SE |
| K880163 | Pregnancy (HCG) Card & Liquid TestJHJ · Traditional | 05/17/1988SE |
| K880478 | Pregnancy Beta-Hcg Card & Liquid TestJHJ · Traditional | 04/28/1988SE |
Questions and answers
When was Group a Strep, Beta-Strep cleared by the FDA?
Group a Strep, Beta-Strep (K884750) received a 510(k) decision of Substantially Equivalent on December 22, 1988, 38 days after the submission was received.
What is the product code of K884750?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.