Accutex Aso Latex Test
FDA 510(k) K924247 · J.S. Medical Assoc.
510(k) numberK924247
Submission
- Device name
- Accutex Aso Latex Test
- Applicant
- J.S. Medical Assoc.
Natick, MA, US - Received
- August 24, 1992
- Decision date
- December 7, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K922723 | Tech Simple Antistreptolysin O Aso Serum ControlGTQ · Traditional | Simplicity Diagnostics, Inc. | 09/18/1992SE |
| 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 |
|---|---|---|
| K932752 | Visi-SpotJTO · Traditional | 11/05/1993SE |
| K932688 | Eye Spot Im TestKTN · Traditional | 09/08/1993SE |
| K932180 | Eye Spot CRP TestDCN · Traditional | 08/23/1993SE |
| K932551 | Accutex Im Latex TestKTN · Traditional | 08/09/1993SE |
| K926112 | Accutex Beta-Hcg TestJHJ · Traditional | 07/28/1993SE |
| K924332 | Accutex CRP Latex TestDCK · Traditional | 12/07/1992SE |
| K924036 | Accutex Rheumatiod Factor (RF) Latex TestDHR · Traditional | 12/01/1992SE |
| K924248 | Accutex Sle Latex TestLJM · Traditional | 11/02/1992SE |
| K924037 | Accutex Im RBC TestKTN · Traditional | 11/02/1992SE |
| K912717 | J&S Uibc ReagentsJMO · Traditional | 09/25/1991SE |
Questions and answers
When was Accutex Aso Latex Test cleared by the FDA?
Accutex Aso Latex Test (K924247) received a 510(k) decision of Substantially Equivalent on December 7, 1992, 105 days after the submission was received.
What is the product code of K924247?
The FDA product code is GTQ – Antistreptolysin - Titer/Streptolysin O Reagent, a Class I (low risk) device regulated under 21 CFR 866.3720.