Amer. Histo-Id Sys Primary Iga 2720-21
FDA 510(k) K842330 · Bartels Immunodiagnostic Supplies, Inc.
510(k) numberK842330
Submission
- Device name
- Amer. Histo-Id Sys Primary Iga 2720-21
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
Mchenry, IL, US - Received
- June 13, 1984
- Decision date
- August 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZP – Iga, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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|---|---|---|---|
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…CZP · Traditional | Horiba Abx SAS | 06/26/2020SE |
| K060130 | Immage Systems Low Concentration Immunoglobulin a ReagentCZP · Special | Beckman Coulter, Inc. | 02/13/2006SE |
| K040435 | Roche Diagnostics Tina-Quant Iga GEN.2CZP · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K024038 | N Latex IgaCZP · Traditional | Dade Behring, Inc. | 02/13/2003SE |
| K993927 | Wako Iga Ii-Ha, Immunoglobulin Calibrator Set, Immunoglobulin StandradCZP · Traditional | Wako Chemicals USA, Inc. | 01/14/2000SE |
| K983359 | IgaCZP · Traditional | Abbott Laboratories | 11/04/1998SE |
| K962200 | Quantex IgaCZP · Traditional | Instrumentation Laboratory CO | 09/25/1996SE |
| K955794 | Iga Immunoturbidimetric & CalibratorCZP · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
| K955907 | Boehringer Mannheim Iga AssayCZP · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K952309 | N Latex IgaCZP · Traditional | Behring Diagnostics, Inc. | 06/20/1995SE |
More from Behring Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864776 | A549 (Human Lung Carcinoma) Culture CellsKIR · Traditional | 12/31/1986SE |
| K861172 | Rotavirus Latex Agglutination AssayLIQ · Traditional | 07/01/1986SE |
| K860279 | Cytomegalovirus Direct Fluorescent Antibody KitLIN · Traditional | 05/13/1986SE |
| K855034 | American Histo-Id Sys Primary Kit Psa Prostate AntLIJ · Traditional | 03/11/1986SE |
| K842830 | Immunoper-Oxidase Test Kit for Detect ofGQN · Traditional | 11/26/1985SE |
| K852185 | Respiratory Syncytial Virus Direct Fluorescent AntLKT · Traditional | 08/19/1985SE |
| K844105 | Fitc Labeled Chlamydiae Monoclonal Antibody · Traditional | 12/06/1984SE |
| K842834 | HEP-2 CellsKJR · Traditional | 08/28/1984SE |
| K842833 | PMK Primary Monkey Kidney-CellsKJR · Traditional | 08/28/1984SE |
| K842328 | Amer. Histo-Id Sys Primary Lambda ChainDEH · Traditional | 08/03/1984SE |
Questions and answers
When was Amer. Histo-Id Sys Primary Iga 2720-21 cleared by the FDA?
Amer. Histo-Id Sys Primary Iga 2720-21 (K842330) received a 510(k) decision of Substantially Equivalent on August 2, 1984, 50 days after the submission was received.
What is the product code of K842330?
The FDA product code is CZP – Iga, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.