LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
FDA 510(k) clearance K780335 · decided 1978-03-22
Clearance details
- K-number
- K780335
- Device name
- LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1978-02-28
- Decision date
- 1978-03-22
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- DBA
- Device class
- 2
- Regulation number
- 866.5250
- 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 |
|---|---|---|
| OPTILITE C1 INACTIVATOR KIT (K141100) | The Binding Site Group , Ltd. | 2014-07-18 |
| HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS (K122304) | The Binding Site Group , Ltd. | 2013-04-15 |
| DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (K072965) | Dade Behring, Inc. | 2007-12-21 |
| K-ASSAY C1-INA (K011780) | Kamiya Biomedical Co. | 2001-07-25 |
| C1-INHIBITOR MICROTITER ASSAY DEVICE (K003747) | Baxter Healthcare Corp | 2001-03-19 |
| N-ASSAY TIA C1-INACTIVATOR TEST KIT (K965024) | Crestat Diagnostics, Inc. | 1997-07-14 |
| N ANTISERUM TO C1 INHIBITOR (K960257) | Behring Diagnostics, Inc. | 1996-08-01 |
| HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (K951967) | Kent Laboratories, Inc. | 1995-05-30 |
| COMPLEMENT C1 INACTIVATOR KIT (K915431) | The Binding Site, Ltd. | 1992-01-17 |
| CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (K872426) | Cytotech, Inc. | 1987-07-23 |
| ORTHO CLASSICAL PATHWAY COMPL. TEST (K821898) | Ortho Diagnostic Systems, Inc. | 1982-07-16 |
| ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) (K781017) | Icl Scientific | 1978-08-14 |
Recalls involving this device
No recalls on record reference this clearance.