Goat Anti-Human Iga a Chain Specific
FDA 510(k) K832257 · Gelco Diagnostics, Inc.
510(k) numberK832257
Submission
- Device name
- Goat Anti-Human Iga a Chain Specific
- Applicant
- Gelco Diagnostics, Inc.
Walker, MI, US - Received
- June 30, 1983
- Decision date
- October 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZN – Iga, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891683 | Titan Gel Ife Free Kappa/Lamba Light Chain AntiserCZN · Traditional | Helena Laboratories | 04/12/1989SE |
| K855011 | Quantimetric Plus C3 Reagent KitCZN · Traditional | Kallestad Laboratories, Inc. | 02/26/1986SE |
| K841815 | Optimate Iga TestCZN · Traditional | Miles Laboratories, Inc. | 06/01/1984SE |
| K832262 | Fitc Goat Anti-Human ImmunoglobulinsCZN · Traditional | Gelco Diagnostics, Inc. | 10/31/1983SE |
| K831909 | Rabbit Antiserum to Human IgaCZN · Traditional | Dako Corp. | 07/18/1983SE |
| K831607 | Fiax Iga Test KitCZN · Traditional | Intl. Diagnostic Technology | 06/22/1983SE |
More from Intl. Diagnostic Technology
| 510(k) | Device | Decision |
|---|---|---|
| K832270 | Goat Anti-Human LambaDEH · Traditional | 10/31/1983SE |
| K832267 | Fitc Goat Anti-Human LambaDES · Traditional | 10/31/1983SE |
| K832266 | Fitc Goat Anti-Human Kappa AffinityDFH · Traditional | 10/31/1983SE |
| K832265 | Fitc Goat Anti-Human Igm H ChainDFT · Traditional | 10/31/1983SE |
| K832263 | Fitc Goat Anti-Human Iga a ChainCZP · Traditional | 10/31/1983SE |
| K832262 | Fitc Goat Anti-Human ImmunoglobulinsCZN · Traditional | 10/31/1983SE |
| K832260 | Goat Anti-Human Kappa AffinityDEO · Traditional | 10/31/1983SE |
| K832258 | Goat Anti-Human Igg Y Chain SpecificDEW · Traditional | 10/31/1983SE |
| K832256 | Goat Anti-Human Immunoglobulins-DFH · Traditional | 10/31/1983SE |
| K832264 | Fitc Goat Anti-Human Igg Y ChainDEW · Traditional | 10/28/1983SE |
Questions and answers
When was Goat Anti-Human Iga a Chain Specific cleared by the FDA?
Goat Anti-Human Iga a Chain Specific (K832257) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 120 days after the submission was received.
What is the product code of K832257?
The FDA product code is CZN – Iga, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.