VARICELLA-ZOSTER(IGG) IFA TEST
FDA 510(k) clearance K841434 · decided 1985-04-19
Clearance details
- K-number
- K841434
- Device name
- VARICELLA-ZOSTER(IGG) IFA TEST
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-06
- Decision date
- 1985-04-19
- Days to decision
- 378 days
- Clearance type
- Traditional
- Product code
- GQW
- Device class
- 2
- Regulation number
- 866.3900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Raritan, NJ, 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 VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 (K070206) | Diagnostic Hybrids, Inc. | 2007-08-30 |
| 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 ANTIGENS & CONTROLS (K802938) | Orion Diagnostica, Inc. | 1980-12-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042) | Zeus Scientific, Inc. | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045) | Zeus Scientific, Inc. | 2017-09-19 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S001) | Zeus Scientific, Inc. | 1992-04-21 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S002) | Zeus Scientific, Inc. | 1992-04-17 |
| FLUORO-CEP (R) PROGESTERONE (P900025) | Zeus Scientific, Inc. | 1990-09-26 |