HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
FDA 510(k) clearance K951967 · decided 1995-05-30
Clearance details
- K-number
- K951967
- Device name
- HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
- Applicant
- Kent Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-27
- Decision date
- 1995-05-30
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- DBA
- Device class
- 2
- Regulation number
- 866.5250
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kent Laboratories
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| LAS-R HUMAN C1 ESTERASE INHIBITOR TEST (K780335) | Hyland Therapeutic Div., Travenol Laboratories | 1978-03-22 |
Recalls involving this device
No recalls on record reference this clearance.