Automated Immunoprecipitin Method/Icg
FDA 510(k) K803272 · Icl Scientific
510(k) numberK803272
Submission
- Device name
- Automated Immunoprecipitin Method/Icg
- Applicant
- Icl Scientific
Mchenry, IL, US - Received
- December 29, 1980
- Decision date
- January 26, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DFZ – Igg (Gamma Chain Specific), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DFZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092283 | Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista…DFZ · Traditional | Siemens Healthcare Diagnostics | 10/21/2009SE |
| K021081 | Human Igg Subclass Liquid Reagent Kits for Use on the Hitachi 911/7070 Turbidimetric…DFZ · Traditional | The Binding Site, Ltd. | 06/17/2002SE |
| K020823 | Peliclass Human Igg Subclass Nephelometric Immage KitDFZ · Traditional | Sanquin Blood Supply Foundation | 05/14/2002SE |
| K955906 | Boehringer Mannheim Igg AssayDFZ · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K940422 | Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array AnalyzerDFZ · Traditional | The Binding Site, Ltd. | 05/27/1994SE |
| K812821 | H-103 Igg, H-104 Iga, H-105 IgmDFZ · Traditional | Immulok, Inc. | 10/26/1981SE |
| K790720 | Antisera to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
| K790709 | Antiserum to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
More from Kent Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883942 | Hycor Sentry Drugs of Abuse Urine ControlJJY · Traditional | 11/10/1988SE |
| K843565 | Kova Trol I,Ii, III Human Urine-DriedJJW · Traditional | 10/05/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
| K823199 | Enzyme-Test DigoxinKXT · Traditional | 11/29/1982SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
| K822465 | Enzymune System IJJE · Traditional | 09/14/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
Questions and answers
When was Automated Immunoprecipitin Method/Icg cleared by the FDA?
Automated Immunoprecipitin Method/Icg (K803272) received a 510(k) decision of Substantially Equivalent on January 26, 1981, 28 days after the submission was received.
What is the product code of K803272?
The FDA product code is DFZ – Igg (Gamma Chain Specific), Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.