Aso-Check
FDA 510(k) K831464 · Diagnostic Technology, Inc.
510(k) numberK831464
Submission
- Device name
- Aso-Check
- Applicant
- Diagnostic Technology, Inc.
Mchenry, IL, US - Received
- May 6, 1983
- Decision date
- June 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Kallestad Diag, A Div. of Erbamont, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896378 | Lyme-Check(Tm) Test KitLSR · Traditional | 11/05/1991SE |
| K903612 | Ebv/Ea-Check TM Test KitLSE · Traditional | 10/16/1990SE |
| K891542 | Ebna-Check(Tm) Test KitLLM · Traditional | 06/20/1989SE |
| K890819 | Hsv-Check(Tm) Test KitHIS · Traditional | 06/20/1989SE |
| K890639 | Resubmitted Ebv/Igm-Check Test KitLJN · Traditional | 06/20/1989SE |
| K871373 | Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional | 06/25/1987SE |
| K864128 | Chlamydia-Check(Tm) Direct & Culture Confir. KitLJP · Traditional | 04/29/1987SE |
| K863408 | Ebv/Vca-Check(Tm) Antigen SlidesGNP · Traditional | 11/28/1986SE |
| K860586 | PHA-2 Conversion Program for Platelet AnalysisGKL · Traditional | 05/07/1986SE |
| K860166 | Picoscale Blood Cell Counter, Model PS-5GKL · Traditional | 04/04/1986SE |
Questions and answers
When was Aso-Check cleared by the FDA?
Aso-Check (K831464) received a 510(k) decision of Substantially Equivalent on June 16, 1983, 41 days after the submission was received.
What is the product code of K831464?
The FDA product code is GTQ – Antistreptolysin - Titer/Streptolysin O Reagent, a Class I (low risk) device regulated under 21 CFR 866.3720.