Serum, B1A Globulin C3C Goat Anti-Human
FDA 510(k) K760148 · Oxford Laboratories, Inc.
510(k) numberK760148
Submission
- Device name
- Serum, B1A Globulin C3C Goat Anti-Human
- Applicant
- Oxford Laboratories, Inc.
Mchenry, IL, US - Received
- June 29, 1976
- Decision date
- July 20, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CZW – Complement C3, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Specialty
- Immunology
Other 510(k)s with product code CZW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100179 | SpaplusCZW · Traditional | The Binding Site Group , Ltd. | 08/13/2010SE |
| K063150 | Complement C3 and C4, Specical Calibrator and Specitrol Control and High ControlCZW · Traditional | Thermo Electron OY | 03/19/2007SE |
| K061852 | Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…CZW · Traditional | Dade Behring, Inc. | 09/22/2006SE |
| K050665 | N Antisera to Human Complement Factors (C3C, C4)CZW · Traditional | Dade Behring, Inc. | 05/02/2005SE |
| K042494 | Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…CZW · Traditional | Ortho-Clinical Diagnostics | 10/19/2004SE |
| K032796 | Ibl C3D-CIC Eia TestCZW · Traditional | Ibl GmbH | 01/13/2004SE |
| K032035 | Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…CZW · Traditional | Beckman Coulter, Inc. | 08/07/2003SE |
| K012361 | Tina-Quant Complement C3C Test SystemCZW · Traditional | Roche Diagnostics Corp. | 11/29/2001SE |
| K010326 | Wako Autokit C3CZW · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| K000469 | Randox Complement C3CZW · Traditional | Randox Laboratories, Ltd. | 03/27/2000SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K780912 | Adjustable DispensorJQW · Traditional | 06/28/1978SE |
| K760147 | Serum, Igm Anti-Human AcidDFT · Traditional | 07/20/1976SE |
| K760146 | Serum, Iga Goat Anti-Human AcidCZP · Traditional | 07/20/1976SE |
| K760144 | Serum, Haptoglobin Goat Anti-Human AcidDAD · Traditional | 07/20/1976SE |
| K760143 | Serum, ALPHA-1-GLYCOPROTEIN Anti-HumanDEX · Traditional | 07/20/1976SE |
| K760079 | Reagent, Thyroxine T4 (#210)CDX · Traditional | 07/20/1976SE |
| K760078 | Reagent, Ria Triiodothyronine T3 (#200)CDP · Traditional | 07/20/1976SE |
| K760145 | Serum, Igg Goat Anti-Human AcidDEW · Traditional | 07/19/1976SE |
Questions and answers
When was Serum, B1A Globulin C3C Goat Anti-Human cleared by the FDA?
Serum, B1A Globulin C3C Goat Anti-Human (K760148) received a 510(k) decision of Substantially Equivalent on July 20, 1976, 21 days after the submission was received.
What is the product code of K760148?
The FDA product code is CZW – Complement C3, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.