Rapid AS Latex
FDA 510(k) K862530 · Dilab, Inc.
510(k) numberK862530
Submission
- Device name
- Rapid AS Latex
- Applicant
- Dilab, Inc.
Miami, FL, US - Received
- July 2, 1986
- Decision date
- April 21, 1987
- 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 |
|---|---|---|
| K850931 | AlbuminCIX · Traditional | 06/26/1985SE |
| K850938 | CholesterolCGO · Traditional | 06/25/1985SE |
| K850936 | Total ProteinsCEK · Traditional | 06/25/1985SE |
| K850934 | PhosphorusCEO · Traditional | 06/25/1985SE |
| K850933 | Uric AcidCDH · Traditional | 06/25/1985SE |
| K850932 | CreatinineCGX · Traditional | 06/25/1985SE |
| K850937 | UreaCDW · Traditional | 06/10/1985SE |
| K850935 | ChlorideCHJ · Traditional | 06/10/1985SE |
| K850930 | GlucoseCGE · Traditional | 06/10/1985SE |
| K850929 | CalciumCIC · Traditional | 06/10/1985SE |
Questions and answers
When was Rapid AS Latex cleared by the FDA?
Rapid AS Latex (K862530) received a 510(k) decision of Substantially Equivalent on April 21, 1987, 293 days after the submission was received.
What is the product code of K862530?
The FDA product code is GTQ – Antistreptolysin - Titer/Streptolysin O Reagent, a Class I (low risk) device regulated under 21 CFR 866.3720.