Cytomegalovirus Antobody Igg
FDA 510(k) K822606 · Immulok, Inc.
510(k) numberK822606
Submission
- Device name
- Cytomegalovirus Antobody Igg
- Applicant
- Immulok, Inc.
Mchenry, IL, US - Received
- August 27, 1982
- Decision date
- November 1, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
Other 510(k)s with product code LIN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081164 | D3 Dfa Cytomegalovirus Immediate Early Antigen Identification KitLIN · Traditional | Diagnostic Hybrids, Inc. | 06/13/2008SE |
| K983762 | Nuclisens CMV PP67LIN · Traditional | Organon Teknika Corp. | 09/15/1999SE |
| K991650 | CMV Brite Turbo KitLIN · Special | Biotest Diagnostics Corp. | 07/12/1999SE |
| K951821 | Cytomegalovirus Direct Immunofluorescence AssayLIN · Traditional | Light Diagnostics | 06/07/1996SE |
| K951550 | CMV Brite Antigenemia Test KitLIN · Traditional | Biotest Diagnostics Corp. | 01/30/1996SE |
| K934798 | Pathodx CytomegalovirusLIN · Traditional | Diagnostic Products Corp. | 03/25/1994SE |
| K921616 | Cmv-Vue(Tm) CMV Antigen Detection KitLIN · Traditional | Incstar Corp. | 08/11/1992SN |
| K912592 | Cmv-Ea Mab TestLIN · Traditional | Gull Laboratories, Inc. | 12/04/1991SE |
| K905257 | Opus CMV Test SystemLIN · Traditional | Pb Diagnostic Systems, Inc. | 04/17/1991SE |
| K904036 | Bartels Cytomegalovirus Immed. Early AntigenLIN · Traditional | Baxter Healthcare Corp | 10/16/1990SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K830971 | Herpes Simplex Virus Typing ReagentsGQL · Traditional | 06/30/1983SE |
| K830342 | Culuture Set Chlamydia Isolation andLKI · Traditional | 05/04/1983SE |
| K830250 | CVT Viral TransportsJTW · Traditional | 02/28/1983SE |
| K823304 | Riaset Prolactin Ria KitCFT · Traditional | 12/22/1982SE |
| K822785 | Fluoroset Immunofluorescent AntibodyGQL · Traditional | 11/29/1982SE |
| K823055 | Flouroset Immunofluorescent AntibodyDHN · Traditional | 11/05/1982SE |
| K822605 | Toxoplasma Gondii Antibody IggLJK · Traditional | 10/27/1982SE |
| K822607 | Antinuclear Antobody Cell SubstrateDHN · Traditional | 09/17/1982SE |
| K821567 | Immulok CulturesetGQL · Traditional | 06/25/1982SE |
| K821411 | Histoset Immunoperofidase TissueGQL · Traditional | 06/25/1982SE |
Questions and answers
When was Cytomegalovirus Antobody Igg cleared by the FDA?
Cytomegalovirus Antobody Igg (K822606) received a 510(k) decision of Substantially Equivalent on November 1, 1982, 66 days after the submission was received.
What is the product code of K822606?
The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.