Aso Sure
FDA 510(k) K820785 · Analytical Products, Inc.
510(k) numberK820785
Submission
- Device name
- Aso Sure
- Applicant
- Analytical Products, Inc.
Mchenry, IL, US - Received
- March 23, 1982
- Decision date
- April 8, 1982
- 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 |
|---|---|---|
| K924814 | Api 20E/UNISCEPT 20EJSS · Traditional | 03/11/1993SE |
| K923684 | Api Uniscept Mic/Type 2 and 3 and Micro MicJWY · Traditional | 12/03/1992SE |
| K922926 | Api Uniscept Kb/Type 2 and 3JWY · Traditional | 10/13/1992SE |
| K901559 | Modification to Api Uniscept 20GPLQL · Traditional | 09/10/1990SE |
| K901390 | Dmac Indole ReagentJTO · Traditional | 04/16/1990SE |
| K895796 | Api Uniscept KBJWY · Traditional | 11/13/1989SE |
| K884510 | Modification Micro-MicJWY · Traditional | 11/22/1988SE |
| K884509 | Modification Mic/Api Uniscept(R)JWY · Traditional | 11/22/1988SE |
| K880598 | Modifications to Api Uniscept (R) KBJWY · Traditional | 03/23/1988SE |
| K874466 | Api Uniscept(R) Micro-Mic(R) System/Uniscept MicJWY · Traditional | 12/09/1987SE |
Questions and answers
When was Aso Sure cleared by the FDA?
Aso Sure (K820785) received a 510(k) decision of Substantially Equivalent on April 8, 1982, 16 days after the submission was received.
What is the product code of K820785?
The FDA product code is GTQ – Antistreptolysin - Titer/Streptolysin O Reagent, a Class I (low risk) device regulated under 21 CFR 866.3720.