Tech Simple Antistreptolysin O Aso Serum Control
FDA 510(k) K922723 · Simplicity Diagnostics, Inc.
510(k) numberK922723
Submission
- Device name
- Tech Simple Antistreptolysin O Aso Serum Control
- Applicant
- Simplicity Diagnostics, Inc.
Hatboro, PA, US - Received
- June 5, 1992
- Decision date
- September 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GTQ – Antistreptolysin - Titer/Streptolysin O Reagent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3720
- Specialty
- Microbiology
Other 510(k)s with product code GTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052645 | Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS…GTQ · Traditional | Ortho-Clinical Diagnostics | 12/14/2005SE |
| K953437 | Olympus Anti-Sterptolysin O Immunoturbidimetric ReagentGTQ · Traditional | Olympus America, Inc. | 10/20/1995SE |
| K915742 | Turbiquant AslGTQ · Traditional | Behring Diagnostics, Inc. | 06/28/1993SE |
| K926236 | Beckman Anti-Streptolysin O KitGTQ · Traditional | Beckman Instruments, Inc. | 06/15/1993SE |
| K924247 | Accutex Aso Latex TestGTQ · Traditional | J.S. Medical Assoc. | 12/07/1992SE |
| K915053 | Beckman Antistreptolysin O, ModificationGTQ · Traditional | Beckman Instruments, Inc. | 03/19/1992SE |
| K912150 | Beckman Anti-Streptolysin O (Aso) KitGTQ · Traditional | Beckman Instruments, Inc. | 07/17/1991SE |
| K904416 | Croatest (R) Rheumatoid DiagnosticGTQ · Traditional | Biotrax, Inc. | 06/24/1991SE |
| K910887 | QM300 Control G PackGTQ · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 06/17/1991SE |
| K910886 | QM300 Antistreptolysin O (Aso) Antigen PackGTQ · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 06/17/1991SE |
More from Kallestad Diag, A Div. of Erbamont, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970100 | Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum ControlMJX · Traditional | 03/10/1997SE |
| K922726 | Tech Simple Infectious Mononucleosis Serum ControlKTN · Traditional | 10/05/1992SE |
| K922725 | Tech Simple Rheumatoid Factor Serum ControlDHR · Traditional | 10/05/1992SE |
| K922722 | Tech Dimple C-Reactive Protein Serum ControlDCK · Traditional | 10/05/1992SE |
Questions and answers
When was Tech Simple Antistreptolysin O Aso Serum Control cleared by the FDA?
Tech Simple Antistreptolysin O Aso Serum Control (K922723) received a 510(k) decision of Substantially Equivalent on September 18, 1992, 105 days after the submission was received.
What is the product code of K922723?
The FDA product code is GTQ – Antistreptolysin - Titer/Streptolysin O Reagent, a Class I (low risk) device regulated under 21 CFR 866.3720.