510(k) K885310
- Device
- MURINE MONOCLONAL ANTI-ADENOVIRUS IGG
- Applicant
- WHITTAKER BIOPRODUCTS, INC.
- 510(k) number
- K885310
- Product code
- GNY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-16
- Date received
- 1988-12-29
- 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
- No
Applicant Contact#
- Contact
- LEIF E OLSEN
- Address
- 8830 Brigg Ford Rd. Walkersville MD US 21793 21793
FDA Registration Numbers#
- 3003750284
- 1419968
- 3004973408
- 3008191245
- 1528450
- 2245285
- 3002800697
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 |
| 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 |
Legacy Summary#
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FDA Review#
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