510(k) K003204
- Device
- BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
- Applicant
- INTRACEL CORP.
- 510(k) number
- K003204
- Product code
- GNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-11-07
- Date received
- 2000-10-13
- Regulation
- 866.3330
- Classification name
- Antisera, Cf, Influenza Virus A, B, C
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHANE WARD
- Address
- 1330 Piccard Dr. Rockville MD US 20850 20850
FDA Registration Numbers#
- 3003750284
- 3002800697
- 3008191245
- 3007208259
- 2032682
- 8010096
- 2029372
- 2245285
- 1528450
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K092882 | D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-10-21 |
| K092300 | MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Diagnostic Hybrids, Inc. | 2009-08-28 |
| K081746 | D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT | Diagnostic Hybrids, Inc. | 2008-12-23 |
| K061101 | D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT | Diagnostic Hybrids, Inc. | 2006-11-20 |
| K022713 | DFA RESPIRATORY VIRUS SCREENING & ID KIT | Diagnostic Hybrids, Inc. | 2002-12-18 |
| K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B | Light Diagnostics | 1998-04-08 |
| K973954 | IMAGEN RESPIRATORY SCREEN | Dako Diagnostics , Ltd. | 1997-12-22 |
| K962037 | IMAGEN RESPIRATORY SCREEN | Dako Diagnostics , Ltd. | 1996-12-26 |
| K942172 | INFLUENZA A ANTIGEN TEST | Neogenex | 1994-07-06 |
| K942174 | INFLUENZA B ANITGEN TEST | Neogenex | 1994-06-30 |
| K913351 | INFLUENZA MAB TEST/INFLUENZA A TEST | Gull Laboratories, Inc. | 1991-12-17 |
| K913214 | INFLUENZA MAB TEST/INFLUENZA B TEST | Gull Laboratories, Inc. | 1991-12-13 |
| K896635 | VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY | Baxter Healthcare Corp | 1990-02-02 |
| K872693 | INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | 1987-09-18 |
| K872694 | YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | 1987-09-18 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases