CMV Igg Antibody Test (Indirect Fluorescent Test)
FDA 510(k) K893468 · Immuno Concepts, Inc.
510(k) numberK893468
Submission
- Device name
- CMV Igg Antibody Test (Indirect Fluorescent Test)
- Applicant
- Immuno Concepts, Inc.
Sacramento, CA, US - Received
- May 3, 1989
- Decision date
- July 14, 1989
- 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
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|---|---|---|---|
| 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 |
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| K983924 | HEP-2000 Colorzyme Ana-Ro Test System, Model 4200-RODHN · Traditional | 12/18/1998SE |
| K972145 | HEP-2000 Fluorescent Ana-Ro Test SystemDHN · Traditional | 02/24/1998SE |
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| K963275 | Relisa Ena Single Well Screen Antibody Test SystemLLL · Traditional | 09/13/1996SE |
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Questions and answers
When was CMV Igg Antibody Test (Indirect Fluorescent Test) cleared by the FDA?
CMV Igg Antibody Test (Indirect Fluorescent Test) (K893468) received a 510(k) decision of Substantially Equivalent on July 14, 1989, 72 days after the submission was received.
What is the product code of K893468?
The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.