Las-R Human Igd Test
FDA 510(k) K772327 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK772327
Submission
- Device name
- Las-R Human Igd Test
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- December 21, 1977
- Decision date
- February 28, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K913671 | Human Igd Immunological NL Test KitCZJ · Traditional | The Binding Site, Ltd. | 12/02/1991SE |
| 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 |
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| K810078 | Q-Pak Therapeutic Drug Monit. Control SDIF · Traditional | 02/02/1981SE |
| K810077 | Omega Therapeutic Drug Monit. Control S.DIF · Traditional | 01/28/1981SE |
| K802610 | Alert A,Hdl-Apoliporotein a, Test KitDER · Traditional | 01/05/1981SE |
| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | 06/28/1979SE |
| K790249 | Test CellsKSF · Traditional | 05/16/1979SE |
| K781225 | Globulin Test, Human Thyroxine BindingCEE · Traditional | 08/31/1978SE |
| K780962 | Automated EnzymeKSK · Traditional | 07/27/1978SE |
Questions and answers
When was Las-R Human Igd Test cleared by the FDA?
Las-R Human Igd Test (K772327) received a 510(k) decision of Substantially Equivalent on February 28, 1978, 69 days after the submission was received.
What is the product code of K772327?
The FDA product code is CZJ – Igd, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.