510(k) K870176
- Device
- GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT
- Applicant
- GENETIC SYSTEMS CORP.
- 510(k) number
- K870176
- Product code
- LKT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-07-16
- Date received
- 1987-01-15
- Regulation
- 866.3480
- Classification name
- Respiratory Syncytial Virus, Antigen, Antibody, Ifa
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BOGDAN DZIURZYNSKI
- Address
- 3005 First Ave. Seattle WA US 98121 98121
FDA Registration Numbers#
- 3003750284
- 1419968
- 3004973408
- 1181055
- 1528450
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081928 | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT | Diagnostic Hybrids, Inc. | 2008-12-23 |
| K983336 | PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 | Diagnostic Products Corp. | 1999-03-18 |
| K943317 | PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) | Diagnostic Products Corp. | 1994-12-19 |
| K942173 | RSV ANTIGEN TEST | Neogenex | 1994-06-30 |
| K912842 | RSV-MAB TEST | Gull Laboratories, Inc. | 1991-12-09 |
| K912838 | BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO | Baxter Diagnostics, Inc. | 1991-09-27 |
| K912371 | BIOMERIEUX RSV DIRECT IF KIT | Vitek Systems, Inc. | 1991-09-23 |
| K894623 | RESPIRATORY SYNCYTIAL VIRUS | Bion Ent., Ltd. | 1989-10-16 |
| K884192 | RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION | Baxter Diagnostics, Inc. | 1988-11-22 |
| K882687 | ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST | Gull Laboratories, Inc. | 1988-08-30 |
| K873564 | GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES | Genetic Systems Corp. | 1987-11-20 |
| K872701 | RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL | Sita, Inc. | 1987-09-18 |
| K872082 | RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE | Medical Diagnostic Technologies, Inc. | 1987-07-31 |
| K871230 | ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| K862321 | CELLMATICS RSV DETECTION SYSTEM | Difco Laboratories, Inc. | 1986-08-21 |
Legacy Summary#
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FDA Review#
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