510(k) K061008
- Device
- QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199
- Applicant
- QUIDEL CORP.
- 510(k) number
- K061008
- Product code
- MCE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-09-08
- Date received
- 2006-04-12
- Regulation
- 866.3480
- Classification name
- Respiratory Syncytial Virus - Elisa
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN D TAMERIUS
- Address
- 10165 Mckellar Ct. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3007361513
- 3002800697
- 3005542422
- 3008191245
- 3007118747
- 3003268355
- 2133982
- 2245285
- 3029917416
Source Documents#
Other 510(k) Records For Product Code MCE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K924289 | KALLESTAD RSV MICROPLATE EIA | Bio-Rad Laboratories, Inc. | 1993-02-12 |
Legacy Summary#
summary
FDA Review#
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