LAS-R HUMAN COMPLEMENT CLQ TEST
FDA 510(k) clearance K780729 · decided 1978-05-18
Clearance details
- K-number
- K780729
- Device name
- LAS-R HUMAN COMPLEMENT CLQ TEST
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1978-05-02
- Decision date
- 1978-05-18
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- DAK
- Device class
- 2
- Regulation number
- 866.5240
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BINDAZYME CLQ CIC EIA KIT (K031563) | The Binding Site, Ltd. | 2003-09-10 |
| IBL C1Q-CIC CIA TEST (K032254) | Ibl GmbH | 2003-08-29 |
| CIC-C1Q EIA (K012576) | American Laboratory Products Co., Ltd. | 2002-01-29 |
| THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES (K973203) | Sangstat Medical Corp. | 1998-09-30 |
| IMMUSTRIP HAMA IGG (K972873) | Immunomedics, Inc. | 1998-03-17 |
| HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (K951968) | Kent Laboratories, Inc. | 1995-05-30 |
| C1 RID KIT (K914388) | The Binding Site, Ltd. | 1991-10-28 |
| CIRCULATING IMMUNE COMPLEXES CONTROLS (K882829) | Cytotech, Inc. | 1988-08-04 |
| SANASSAY IC TEST (K860996) | Scientific Sales Intl., Inc. | 1987-03-30 |
| IC MICROASSAY (K864312) | Diamedix Corp. | 1987-01-09 |
| CYTOTECH CIC ENZYME IMMUNOASSAY (K862649) | Cytotech, Inc. | 1986-09-04 |
| BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT (K861499) | Biostar Medical Products, Inc. | 1986-06-20 |
Recalls involving this device
No recalls on record reference this clearance.