510(k) K781022
- Device
- ANTI-HUMAN CIQ SERUM
- Applicant
- ICL SCIENTIFIC
- 510(k) number
- K781022
- Product code
- DAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-14
- Date received
- 1978-06-19
- Regulation
- 866.5240
- Classification name
- Complement C1q, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010127294
- 3012348571
- 3019906
- 1000191380
- 2242436
- 1528450
- 3012471076
- 2026994
- 9614373
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 |
| K951968 | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-05-30 |
| 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 |
Legacy Summary#
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FDA Review#
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