510(k) K922801
- Device
- RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
- Applicant
- LIGHT DIAGNOSTICS
- 510(k) number
- K922801
- Product code
- GNY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-01-06
- Date received
- 1992-06-10
- Regulation
- 866.3020
- Classification name
- Antisera, Fluorescent, Adenovirus 1-33
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE DEMBROW
- Address
- 27520 Enterprise Cir. W. Temecula CA US 92390 92390
FDA Registration Numbers#
- 3003750284
- 3002800697
- 3008191245
- 1419968
- 2245285
- 3004973408
- 1528450
Source Documents#
Other 510(k) Records For Product Code GNY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
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FDA Review#
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