510(k) K971101
- Device
- Hsv-2 Antigen Control Slides
- Applicant
- VIRAL ANTIGENS, INC.
- 510(k) number
- K971101
- Product code
- GQN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-01
- Date received
- 1997-03-26
- Regulation
- 866.3305
- Classification name
- Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERRY S RATCLIFFE
- Address
- 5171 Wilfong Rd. Memphis TN US 38134 38134
FDA Registration Numbers#
- 1528450
- 8010096
- 3003750284
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GQN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070265 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 | Diagnostic Hybrids, Inc. | 2007-10-24 |
| K063798 | DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 | Diagnostic Hybrids, Inc. | 2007-09-21 |
| K991880 | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY | Light Diagnostics | 1999-11-09 |
| K971662 | ELVIS HSV ID/TYPING TEST SYSTEM | Diagnostic Hybrids, Inc. | 1997-11-18 |
| K964874 | HSV-1 ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-07-01 |
| K960578 | ELVIS HSV GOLD | Diagnostic Hybrids, Inc. | 1996-09-05 |
| K941924 | ELVIS HSV | Diagnostic Hybrids, Inc. | 1995-05-01 |
| K911345 | HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT | Diagnostic Hybrids, Inc. | 1991-06-17 |
| K884761 | MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. | Difco Laboratories, Inc. | 1988-12-05 |
| K883684 | HERPES VIRUS CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-09-28 |
| K873529 | HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT | Diagnostic Hybrids, Inc. | 1988-08-25 |
| K880604 | COLORGENE HSV DNA HYBRIDIZATION TEST | Enzo Biochem, Inc. | 1988-08-03 |
| K875311 | WELLCOZYME HSV WZO2 | Wellcome Diagnostics | 1988-08-03 |
| K881180 | FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG | Whittaker Bioproducts, Inc. | 1988-05-13 |
| K880996 | FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG | Whittaker Bioproducts, Inc. | 1988-05-13 |