Titan Gel Ife Antiserum to IGD-9409 & IGE-9410
FDA 510(k) K872834 · Helena Laboratories
510(k) numberK872834
Submission
- Device name
- Titan Gel Ife Antiserum to IGD-9409 & IGE-9410
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- July 17, 1987
- Decision date
- August 12, 1987
- 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 |
| 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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| K024162 | Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional | 02/19/2003SE |
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Questions and answers
When was Titan Gel Ife Antiserum to IGD-9409 & IGE-9410 cleared by the FDA?
Titan Gel Ife Antiserum to IGD-9409 & IGE-9410 (K872834) received a 510(k) decision of Substantially Equivalent on August 12, 1987, 26 days after the submission was received.
What is the product code of K872834?
The FDA product code is CZJ – Igd, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.