Nuclisens CMV PP67
FDA 510(k) K983762 · Organon Teknika Corp.
510(k) numberK983762
Submission
- Device name
- Nuclisens CMV PP67
- Applicant
- Organon Teknika Corp.
Durham, NC, US - Received
- October 26, 1998
- Decision date
- September 15, 1999
- 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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|---|---|---|---|
| K081164 | D3 Dfa Cytomegalovirus Immediate Early Antigen Identification KitLIN · Traditional | Diagnostic Hybrids, Inc. | 06/13/2008SE |
| 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 |
| K894002 | Cytomegalovirus Fluorescent Monoclonal AntibodyLIN · Traditional | Baxter Healthcare Corp | 08/10/1989SE |
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| K992401 | Bact/Alert PFMDB · Traditional | 09/03/1999SE |
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Questions and answers
When was Nuclisens CMV PP67 cleared by the FDA?
Nuclisens CMV PP67 (K983762) received a 510(k) decision of Substantially Equivalent on September 15, 1999, 324 days after the submission was received.
What is the product code of K983762?
The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.