Technicon DPA-1 Immunoglobulin G
FDA 510(k) K883494 · Technicon Instruments Corp.
510(k) numberK883494
Submission
- Device name
- Technicon DPA-1 Immunoglobulin G
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- August 16, 1988
- Decision date
- September 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAH – Gamma Globulin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931247 | Titan Gel IMMUNOFIX-9 Cat. No. 3051 and 3067DAH · Traditional | Helena Laboratories | 04/27/1993SE |
| K905149 | Titan GelDAH · Traditional | Helena Laboratories | 01/03/1991SE |
| K901805 | Rep(R) ImmunofixDAH · Traditional | Helena Laboratories | 06/06/1990SE |
| K884074 | Immunochemical Determination of Immunoglobulin GDAH · Traditional | Orion Diagnostica, Inc. | 10/27/1988SE |
| K854944 | TDX Immunoglobulin M Diagnostic KitDAH · Traditional | Abbott Laboratories | 08/27/1986SE |
| K862184 | Dako Ita, Immunoglobulin M (Igm)DAH · Traditional | Dako Corp. | 08/19/1986SE |
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| 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 DPA-1 Immunoglobulin G cleared by the FDA?
Technicon DPA-1 Immunoglobulin G (K883494) received a 510(k) decision of Substantially Equivalent on September 7, 1988, 22 days after the submission was received.
What is the product code of K883494?
The FDA product code is DAH – Gamma Globulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.