510(k) K770807
- Device
- ADENOVIRUS-GROUP FA LABELLED (8-651 RF)
- Applicant
- Flow Laboratories, Inc.
- 510(k) number
- K770807
- Product code
- GNY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-05-20
- Date received
- 1977-05-03
- Regulation
- 866.3020
- Classification name
- Antisera, Fluorescent, Adenovirus 1-33
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003750284
- 3002800697
- 3008191245
- 1419968
- 2245285
- 3004973408
- 1528450
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNY#
| 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 |
| K770811 | ADENOVIRUS GROUP-FA LABELLED PRESERUM | Flow Laboratories, Inc. | 1977-05-20 |