Cytomegalovirus Direct Immunofluorescence Assay
FDA 510(k) K951821 · Light Diagnostics
510(k) numberK951821
Submission
- Device name
- Cytomegalovirus Direct Immunofluorescence Assay
- Applicant
- Light Diagnostics
Temecula, CA, US - Received
- April 20, 1995
- Decision date
- June 7, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K983762 | Nuclisens CMV PP67LIN · Traditional | Organon Teknika Corp. | 09/15/1999SE |
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| K951550 | CMV Brite Antigenemia Test KitLIN · Traditional | Biotest Diagnostics Corp. | 01/30/1996SE |
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| 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 |
| K894002 | Cytomegalovirus Fluorescent Monoclonal AntibodyLIN · Traditional | Baxter Healthcare Corp | 08/10/1989SE |
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| K972975 | Light Diagnostics Rabies Dfa ReagentGOI · Traditional | 12/22/1998SE |
| K974302 | Light Diagnostics Simulfluor Flu A/Flu BGNW · Traditional | 04/08/1998SE |
| K951799 | Varicella-Zoster Virus Direct Immunofluorescence AssayGQX · Traditional | 03/20/1996SE |
| K940034 | Poliovirus 2 Monoclonal AntibodyGOE · Traditional | 09/12/1995SE |
| K940026 | Poliovirus Blend Monoclonal AntibodiesGOE · Traditional | 09/12/1995SE |
| K940017 | Poliovirus 3 Monoclonal AntibodyGOE · Traditional | 09/12/1995SE |
| K940363 | Enterovirus 70 Monclonal AntibodyGOE · Traditional | 09/08/1995SE |
| K940018 | Poliovirus 1 Monoclonal AntibodyGOE · Traditional | 09/08/1995SE |
Questions and answers
When was Cytomegalovirus Direct Immunofluorescence Assay cleared by the FDA?
Cytomegalovirus Direct Immunofluorescence Assay (K951821) received a 510(k) decision of Substantially Equivalent on June 7, 1996, 414 days after the submission was received.
What is the product code of K951821?
The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.