510(k) K011780
- Device
- K-ASSAY C1-INA
- Applicant
- Kamiya Biomedical Co.
- 510(k) number
- K011780
- Product code
- DBA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-25
- Date received
- 2001-06-07
- Regulation
- 866.5250
- Classification name
- Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- COLIN GETTY
- Address
- 910 Industry Dr. Seattle WA US 98188 98188
FDA Registration Numbers#
- 3019906
- 9610806
- 1528450
- 3012471076
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
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| K965024 | N-ASSAY TIA C1-INACTIVATOR TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 |
| K960257 | N ANTISERUM TO C1 INHIBITOR | Behring Diagnostics, Inc. | 1996-08-01 |
| K951967 | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-05-30 |
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| K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | Cytotech, Inc. | 1987-07-23 |
| K821898 | ORTHO CLASSICAL PATHWAY COMPL. TEST | Ortho Diagnostic Systems, Inc. | 1982-07-16 |
| K781017 | ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) | Icl Scientific | 1978-08-14 |
| K780335 | LAS-R HUMAN C1 ESTERASE INHIBITOR TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-03-22 |