Prolex (Streptoccal Grouping Latex Kit)
FDA 510(k) K934383 · Pro-Lab, Inc.
510(k) numberK934383
Submission
- Device name
- Prolex (Streptoccal Grouping Latex Kit)
- Applicant
- Pro-Lab, Inc.
Richmond Hill, Ontario, CA - Received
- September 9, 1993
- Decision date
- January 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K914419 | Amniotest(Tm)HIO · Traditional | 09/01/1993SE |
| K921421 | Legionella Reagens for Direct Fluorescent AntibodyLHL · Traditional | 07/28/1992SE |
| K903714 | E. Coli 0157 Latex TestGNA · Traditional | 01/24/1991SE |
| K894221 | Rosco PyrrJTO · Traditional | 09/28/1989SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | 03/20/1987SE |
| K861142 | Master Kit BLRP · Traditional | 07/10/1986SESD |
| K861889 | D'Ala Rapid TestJTO · Traditional | 06/03/1986SE |
Questions and answers
When was Prolex (Streptoccal Grouping Latex Kit) cleared by the FDA?
Prolex (Streptoccal Grouping Latex Kit) (K934383) received a 510(k) decision of Substantially Equivalent on January 27, 1995, 505 days after the submission was received.
What is the product code of K934383?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.