DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
FDA 510(k) clearance K070265 · decided 2007-10-24
Clearance details
- K-number
- K070265
- Device name
- DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
- Applicant
- Diagnostic Hybrids, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-29
- Decision date
- 2007-10-24
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- GQN
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Athens, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000 (K063798) | Diagnostic Hybrids, Inc. | 2007-09-21 |
| LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (K991880) | Light Diagnostics | 1999-11-09 |
| ELVIS HSV ID/TYPING TEST SYSTEM (K971662) | Diagnostic Hybrids, Inc. | 1997-11-18 |
| HSV-1 ANTIGEN CONTROL SLIDES (K964874) | Viral Antigens, Inc. | 1997-07-01 |
| HSV-2 ANTIGEN CONTROL SLIDES (K971101) | Viral Antigens, Inc. | 1997-07-01 |
| ELVIS HSV GOLD (K960578) | Diagnostic Hybrids, Inc. | 1996-09-05 |
| ELVIS HSV (K941924) | Diagnostic Hybrids, Inc. | 1995-05-01 |
| HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT (K911345) | Diagnostic Hybrids, Inc. | 1991-06-17 |
| MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. (K884761) | Difco Laboratories, Inc. | 1988-12-05 |
| HERPES VIRUS CONTROL SLIDES (K883684) | Val Tech Diagnostics, Inc. | 1988-09-28 |
| HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT (K873529) | Diagnostic Hybrids, Inc. | 1988-08-25 |
| WELLCOZYME HSV WZO2 (K875311) | Wellcome Diagnostics | 1988-08-03 |
Recalls involving this device
No recalls on record reference this clearance.