Cytomegalovirus Direct Fluorescent Antibody Kit
FDA 510(k) K860279 · Bartels Immunodiagnostic Supplies, Inc.
510(k) numberK860279
Submission
- Device name
- Cytomegalovirus Direct Fluorescent Antibody Kit
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
Bellevue, WA, US - Received
- January 14, 1986
- Decision date
- May 13, 1986
- 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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|---|---|---|---|
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| 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 |
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| K904036 | Bartels Cytomegalovirus Immed. Early AntigenLIN · Traditional | Baxter Healthcare Corp | 10/16/1990SE |
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Questions and answers
When was Cytomegalovirus Direct Fluorescent Antibody Kit cleared by the FDA?
Cytomegalovirus Direct Fluorescent Antibody Kit (K860279) received a 510(k) decision of Substantially Equivalent on May 13, 1986, 119 days after the submission was received.
What is the product code of K860279?
The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.