Vzvscan(Tm) Latex Aggutination Test
FDA 510(k) K912239 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK912239
Submission
- Device name
- Vzvscan(Tm) Latex Aggutination Test
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- May 21, 1991
- Decision date
- June 11, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GQW – Antigen, Cf, (Including Cf Control), Varicella-Zoster
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3900
- Specialty
- Microbiology
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|---|---|---|---|
| K070206 | Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000GQW · Traditional | Diagnostic Hybrids, Inc. | 08/30/2007SE |
| K990141 | Light Diagnostics Simulfluor Hsv/Vzv Immunoflourescence Assay, Model 3295GQW · Traditional | Light Diagnostics | 10/19/1999SE |
| K964872 | VZV Antigen Control SlidesGQW · Traditional | Viral Antigens, Inc. | 03/18/1997SE |
| K942743 | Viro Varicella-Zoster Virus Identification ReagentGQW · Traditional | Viro Research, Inc. | 12/15/1994SE |
| K903882 | Varicella-Zoster Virus Antibody Test Kit-Latex AggGQW · Traditional | Viral Antigens, Inc. | 12/04/1990SE |
| K894622 | Varicella Zoster VirusGQW · Traditional | Bion Ent., Ltd. | 10/24/1989SE |
| K843676 | Varicella/Zoster VirusGQW · Traditional | Institute Virion , Ltd. | 09/26/1985SE |
| K841434 | Varicella-Zoster(Igg) Ifa TestGQW · Traditional | Zeus Scientific, Inc. | 04/19/1985SE |
| K802938 | Varicella-Zoster Antigens & ControlsGQW · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
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| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
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| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Vzvscan(Tm) Latex Aggutination Test cleared by the FDA?
Vzvscan(Tm) Latex Aggutination Test (K912239) received a 510(k) decision of Substantially Equivalent on June 11, 1991, 21 days after the submission was received.
What is the product code of K912239?
The FDA product code is GQW – Antigen, Cf, (Including Cf Control), Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.