510(k) K951968
- Device
- HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
- Applicant
- KENT LABORATORIES, INC.
- 510(k) number
- K951968
- Product code
- DAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-30
- Date received
- 1995-04-27
- Regulation
- 866.5240
- Classification name
- Complement C1q, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD A JORGENSEN
- Address
- 23404 NE 8th St. Redmond WA US 98053 98053
FDA Registration Numbers#
- 9614373
- 2026994
- 3012348571
- 1000191380
- 3012471076
- 2242436
- 3010127294
- 1528450
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031563 | BINDAZYME CLQ CIC EIA KIT | The Binding Site, Ltd. | 2003-09-10 |
| K032254 | IBL C1Q-CIC CIA TEST | Ibl GmbH | 2003-08-29 |
| K012576 | CIC-C1Q EIA | American Laboratory Products Co., Ltd. | 2002-01-29 |
| K973203 | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES | Sangstat Medical Corp. | 1998-09-30 |
| K972873 | IMMUSTRIP HAMA IGG | Immunomedics, Inc. | 1998-03-17 |
| K914388 | C1 RID KIT | The Binding Site, Ltd. | 1991-10-28 |
| K882829 | CIRCULATING IMMUNE COMPLEXES CONTROLS | Cytotech, Inc. | 1988-08-04 |
| K860996 | SANASSAY IC TEST | Scientific Sales Intl., Inc. | 1987-03-30 |
| K864312 | IC MICROASSAY | Diamedix Corp. | 1987-01-09 |
| K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY | Cytotech, Inc. | 1986-09-04 |
| K861499 | BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | 1986-06-20 |
| K853697 | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | 1985-12-16 |
| K851202 | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL | Gilford | 1985-04-29 |
| K844294 | CORDIA IC | Cordis Corp. | 1985-02-04 |
| K833275 | GMP CIQ ELISA TEST KIT | Gamma Medical Products, Inc. | 1984-06-22 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases