Cylomegalovirus Direct Fluorescent Anti
FDA 510(k) K820895 · Bartels Immunodiagnostic Supplies, Inc.
510(k) numberK820895
Submission
- Device name
- Cylomegalovirus Direct Fluorescent Anti
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
Mchenry, IL, US - Received
- March 30, 1982
- Decision date
- May 3, 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
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|---|---|---|---|
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| 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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Questions and answers
When was Cylomegalovirus Direct Fluorescent Anti cleared by the FDA?
Cylomegalovirus Direct Fluorescent Anti (K820895) received a 510(k) decision of Substantially Equivalent on May 3, 1982, 34 days after the submission was received.
What is the product code of K820895?
The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.