Cmv-Vue(Tm) CMV Antigen Detection Kit
FDA 510(k) K921616 · Incstar Corp.
510(k) numberK921616
Submission
- Device name
- Cmv-Vue(Tm) CMV Antigen Detection Kit
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- April 6, 1992
- Decision date
- August 11, 1992
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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
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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 |
| 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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| K963296 | Incstar Toxoplasma Igg Alisa Assay (CAT.#7565)LGD · Traditional | 12/16/1996SE |
| K960367 | Incstar Rubella Igg Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960358 | Incstar Rubella Igg Fast Elisa AssayLFX · Traditional | 10/24/1996SE |
| K960434 | Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530LFZ · Traditional | 10/17/1996SE |
| K953567 | Incstar 25-HYDROXYVITMIN D 1251 RiaMRG · Traditional | 09/25/1996SE |
| K955363 | Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955362 | Incstar HSV I/Ii Igg Fast Elisa AssayIGC · Traditional | 07/24/1996SE |
| K955361 | Incstar Cytomegalovirus Igg Elisa AssayLFZ · Traditional | 07/22/1996SE |
Questions and answers
When was Cmv-Vue(Tm) CMV Antigen Detection Kit cleared by the FDA?
Cmv-Vue(Tm) CMV Antigen Detection Kit (K921616) received a 510(k) decision of Substantially Equivalent for Some Indications on August 11, 1992, 127 days after the submission was received.
What is the product code of K921616?
The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.