Optimate Iga Test
FDA 510(k) K841815 · Miles Laboratories, Inc.
510(k) numberK841815
Submission
- Device name
- Optimate Iga Test
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- May 1, 1984
- Decision date
- June 1, 1984
- 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 |
| K832262 | Fitc Goat Anti-Human ImmunoglobulinsCZN · Traditional | Gelco Diagnostics, Inc. | 10/31/1983SE |
| K832257 | Goat Anti-Human Iga a Chain SpecificCZN · Traditional | Gelco Diagnostics, Inc. | 10/28/1983SE |
| K831909 | Rabbit Antiserum to Human IgaCZN · Traditional | Dako Corp. | 07/18/1983SE |
| K831607 | Fiax Iga Test KitCZN · Traditional | Intl. Diagnostic Technology | 06/22/1983SE |
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Questions and answers
When was Optimate Iga Test cleared by the FDA?
Optimate Iga Test (K841815) received a 510(k) decision of Substantially Equivalent on June 1, 1984, 31 days after the submission was received.
What is the product code of K841815?
The FDA product code is CZN – Iga, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.