Technicon RA-1000 Sys, Analytes III
FDA 510(k) K821514 · Technicon Instruments Corp.
510(k) numberK821514
Submission
- Device name
- Technicon RA-1000 Sys, Analytes III
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- May 10, 1982
- Decision date
- May 10, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JEJ – Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code JEJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874705 | Easy-Test Amylase (Amyl), Item Number 19019JEJ · Traditional | Em Diagnostic Systems, Inc. | 12/22/1987SE |
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| K914511 | Technicon Axon(Tm) System Methods Anyalye HDL CholLBS · Traditional | 11/27/1991SE |
| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | 11/22/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
| K912413 | Chem-Link Data Base ManagerJJQ · Traditional | 07/01/1991SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Technicon RA-1000 Sys, Analytes III cleared by the FDA?
Technicon RA-1000 Sys, Analytes III (K821514) received a 510(k) decision of Substantially Equivalent on May 10, 1982, 0 days after the submission was received.
What is the product code of K821514?
The FDA product code is JEJ – Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating), a Class II (moderate risk) device regulated under 21 CFR 874.4680.