Abbott Testpack Plus Strep a with on Board Controls (Obc) II
FDA 510(k) K971522 · Abbott Laboratories
510(k) numberK971522
Submission
- Device name
- Abbott Testpack Plus Strep a with on Board Controls (Obc) II
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- April 25, 1997
- Decision date
- March 3, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
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| K991726 | Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test KIT),(12 Test Kit)…GTZ · Traditional | Binax, Inc. | 08/27/1999SE |
| 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 |
| K960712 | Binax Strep a TestGTZ · Traditional | Binax, Inc. | 03/22/1996SE |
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Questions and answers
When was Abbott Testpack Plus Strep a with on Board Controls (Obc) II cleared by the FDA?
Abbott Testpack Plus Strep a with on Board Controls (Obc) II (K971522) received a 510(k) decision of Substantially Equivalent on March 3, 1998, 312 days after the submission was received.
What is the product code of K971522?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.