DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
FDA 510(k) clearance K070206 · decided 2007-08-30
Clearance details
- K-number
- K070206
- Device name
- DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
- Applicant
- Diagnostic Hybrids, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-22
- Decision date
- 2007-08-30
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- GQW
- Device class
- 2
- Regulation number
- 866.3900
- 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 |
|---|---|---|
| LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 (K990141) | Light Diagnostics | 1999-10-19 |
| VZV ANTIGEN CONTROL SLIDES (K964872) | Viral Antigens, Inc. | 1997-03-18 |
| VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT (K942743) | Viro Research, Inc. | 1994-12-15 |
| VZVSCAN(TM) LATEX AGGUTINATION TEST (K912239) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-06-11 |
| VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG (K903882) | Viral Antigens, Inc. | 1990-12-04 |
| VARICELLA ZOSTER VIRUS (K894622) | Bion Ent., Ltd. | 1989-10-24 |
| VARICELLA/ZOSTER VIRUS (K843676) | Institute Virion , Ltd. | 1985-09-26 |
| VARICELLA-ZOSTER(IGG) IFA TEST (K841434) | Zeus Scientific, Inc. | 1985-04-19 |
| VARICELLA-ZOSTER ANTIGENS & CONTROLS (K802938) | Orion Diagnostica, Inc. | 1980-12-31 |
Recalls involving this device
No recalls on record reference this clearance.