Pharmacia Cap System Ige Feia -- Modification
FDA 510(k) K923832 · Kabi Pharmacia, Inc.
510(k) numberK923832
Submission
- Device name
- Pharmacia Cap System Ige Feia -- Modification
- Applicant
- Kabi Pharmacia, Inc.
New Brunswick, NJ, US - Received
- July 28, 1992
- Decision date
- November 25, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| K133404 | Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMHDGC · Special | Phadia AB | 02/24/2014SE |
| K063425 | Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…DGC · Traditional | Dade Behring, Inc. | 02/15/2007SE |
| K050493 | Quantia IgeDGC · Traditional | Biokit, S.A. | 08/16/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | Kamiya Biomedical Co. | 12/10/2004SE |
| K034057 | LacrytestDGC · Traditional | Adiatec SA | 03/09/2004SE |
More from Adiatec SA
| 510(k) | Device | Decision |
|---|---|---|
| K915083 | Coamate(R) Antithrombin Chromogenic AssayJBQ · Traditional | 01/03/1992SE |
Questions and answers
When was Pharmacia Cap System Ige Feia -- Modification cleared by the FDA?
Pharmacia Cap System Ige Feia -- Modification (K923832) received a 510(k) decision of Substantially Equivalent on November 25, 1992, 120 days after the submission was received.
What is the product code of K923832?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.