Product code GNY
- Device name
- Antisera, Fluorescent, Adenovirus 1-33
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3020
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K922801 | RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | 1993-01-06 |
| K885310 | MURINE MONOCLONAL ANTI-ADENOVIRUS IGG | Whittaker Bioproducts, Inc. | 1989-02-16 |
| K770807 | ADENOVIRUS-GROUP FA LABELLED (8-651 RF) | Flow Laboratories, Inc. | 1977-05-20 |
| K770811 | ADENOVIRUS GROUP-FA LABELLED PRESERUM | Flow Laboratories, Inc. | 1977-05-20 |
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