CMV Brite Turbo Kit
FDA 510(k) K991650 · Biotest Diagnostics Corp.
510(k) numberK991650
Submission
- Device name
- CMV Brite Turbo Kit
- Applicant
- Biotest Diagnostics Corp.
Denville, NJ, US - Received
- May 13, 1999
- Decision date
- July 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code LIN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K983842 | Biotest Anti-Ebv Recombinant, Ea IgmLSE · Traditional | 06/09/1999SE |
| K983841 | Biotest Anti-Ebv Recombinant, Ebna IggLSE · Traditional | 06/09/1999SE |
| K983839 | Biotest Anti-Ebv RecombinantLSE · Traditional | 06/09/1999SE |
| K951550 | CMV Brite Antigenemia Test KitLIN · Traditional | 01/30/1996SE |
Questions and answers
When was CMV Brite Turbo Kit cleared by the FDA?
CMV Brite Turbo Kit (K991650) received a 510(k) decision of Substantially Equivalent on July 12, 1999, 60 days after the submission was received.
What is the product code of K991650?
The FDA product code is LIN – Antisera, Conjugated Fluorescent, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.