Rapi/Tex Aso Standard Serum
FDA 510(k) K800642 · Calbiochem-Behring Corp.
510(k) numberK800642
Submission
- Device name
- Rapi/Tex Aso Standard Serum
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- March 24, 1980
- Decision date
- April 24, 1980
- 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 |
|---|---|---|
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | 07/28/1983SE |
| K831036 | Ena Test Kit SM & RNP Auto AntibodyLLL · Traditional | 04/27/1983SE |
| K830214 | Aft System IIIDHN · Traditional | 03/09/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | 04/12/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | 03/04/1982SE |
| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | 01/26/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
Questions and answers
When was Rapi/Tex Aso Standard Serum cleared by the FDA?
Rapi/Tex Aso Standard Serum (K800642) received a 510(k) decision of Substantially Equivalent on April 24, 1980, 31 days after the submission was received.
What is the product code of K800642?
The FDA product code is GTQ – Antistreptolysin - Titer/Streptolysin O Reagent, a Class I (low risk) device regulated under 21 CFR 866.3720.