Properdin Factor B for Technicon DPA-1(TM) System
FDA 510(k) K882623 · Technicon Instruments Corp.
510(k) numberK882623
Submission
- Device name
- Properdin Factor B for Technicon DPA-1(TM) System
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- June 24, 1988
- Decision date
- July 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZH – Factor B, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5320
- Specialty
- Immunology
Other 510(k)s with product code JZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964843 | Immage Immunochemistry System Properdin Factor B (PFB) ReagentJZH · Traditional | Beckman Instruments, Inc. | 03/06/1997SE |
| K831959 | Radial Immuno-Test for Human Factor BJZH · Traditional | Kent Laboratories, Inc. | 07/19/1983SE |
| K811740 | Kallestad's Endoplate Factor B TestJZH · Traditional | Kallestad Laboratories, Inc. | 07/16/1981SE |
| K781016 | C3PA (GBG) Properdin Factor BJZH · Traditional | Icl Scientific | 08/14/1978SE |
| K772084 | Las-R Human C3 Proactivator TestJZH · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 01/24/1978SE |
More from Hyland Therapeutic Div., Travenol Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K914888 | Technicon Chem 1(TM) Syst (GEN2 Syst)CIX · Traditional | 11/27/1991SE |
| 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 Properdin Factor B for Technicon DPA-1(TM) System cleared by the FDA?
Properdin Factor B for Technicon DPA-1(TM) System (K882623) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 14 days after the submission was received.
What is the product code of K882623?
The FDA product code is JZH – Factor B, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5320.