Gelman Ig-Fix Kit
FDA 510(k) K812253 · Gelman Sciences, Inc.
510(k) numberK812253
Submission
- Device name
- Gelman Ig-Fix Kit
- Applicant
- Gelman Sciences, Inc.
Mchenry, IL, US - Received
- August 11, 1981
- Decision date
- September 1, 1981
- 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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| 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 |
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| K941589 | Syringe Filter DevicesFMF · Traditional | 09/06/1994SE |
| K941020 | Drug Reconstitution Filter DeviceFMF · Traditional | 08/10/1994SE |
| K942275 | Vial Vent FilterFPB · Traditional | 07/26/1994SE |
| K941032 | UnknownFMF · Traditional | 05/27/1994SE |
| K910821 | Transducer ProtectorFIB · Traditional | 08/12/1991SE |
| K892387 | Modified Gelman Arterial FilterDTM · Traditional | 06/22/1989SE |
| K884176 | Chromatography KitDPA · Traditional | 04/04/1989SE |
| K884178 | Drug Control SetDIF · Traditional | 02/17/1989SE |
Questions and answers
When was Gelman Ig-Fix Kit cleared by the FDA?
Gelman Ig-Fix Kit (K812253) received a 510(k) decision of Substantially Equivalent on September 1, 1981, 21 days after the submission was received.
What is the product code of K812253?
The FDA product code is CZP – Iga, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.