Human Igd Immunological NL Test Kit
FDA 510(k) K913671 · The Binding Site, Ltd.
510(k) numberK913671
Submission
- Device name
- Human Igd Immunological NL Test Kit
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- August 19, 1991
- Decision date
- December 2, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CZJ – Igd, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092450 | Human Igd Kit for Use on SpaplusCZJ · Traditional | The Binding Site | 12/28/2009SE |
| K051299 | Igd Diagnostic Test KitsCZJ · Traditional | The Binding Site, Ltd. | 11/23/2005SE |
| K002561 | Sheep Anti-Human Igd Immunofixation Grade KitCZJ · Traditional | The Binding Site, Ltd. | 10/26/2000SE |
| K883001 | QM300 Calibrator D PackCZJ · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/22/1988SE |
| K872834 | Titan Gel Ife Antiserum to IGD-9409 & IGE-9410CZJ · Traditional | Helena Laboratories | 08/12/1987SE |
| K831956 | Determ. Size 72 Radial-Human IgdCZJ · Traditional | Kent Laboratories, Inc. | 07/18/1983SE |
| K772327 | Las-R Human Igd TestCZJ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 02/28/1978SE |
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| K100455 | Spaplus AnalyzerDBI · Traditional | 09/03/2010SE |
| K090920 | Human Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P)CFN · Traditional | 12/30/2009SE |
| K092450 | Human Igd Kit for Use on SpaplusCZJ · Traditional | 12/28/2009SE |
| K083289 | Human BETA-2 Microglobulin KitJZG · Traditional | 05/06/2009SE |
| K082129 | Human Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerCFN · Traditional | 02/10/2009SE |
| K081827 | Human Iga Liquid Reagent Kit for Use on SpaplusCFN · Traditional | 12/19/2008SE |
Questions and answers
When was Human Igd Immunological NL Test Kit cleared by the FDA?
Human Igd Immunological NL Test Kit (K913671) received a 510(k) decision of Substantially Equivalent on December 2, 1991, 105 days after the submission was received.
What is the product code of K913671?
The FDA product code is CZJ – Igd, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.