510(k) K981226
- Device
- IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3
- Applicant
- DAKO DIAGNOSTICS LTD.
- 510(k) number
- K981226
- Product code
- GQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-28
- Date received
- 1998-03-24
- Regulation
- 866.3400
- Classification name
- Antisera, Neutralization, Parainfluenza Virus 1-4
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RON NEWSTEAD
- Address
- Denmark House, Angel Drove, Ely Cambridgeshire GB CB7 4ET CB7 4ET
FDA Registration Numbers#
- 3008191245
Source Documents#
Other 510(k) Records For Product Code GQP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933575 | VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT | Symex Corp. | 1994-11-28 |
Legacy Summary#
summary
FDA Review#
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