Cmv-Igm Ifa Test System
FDA 510(k) K900743 · Zeus Scientific, Inc.
510(k) numberK900743
Submission
- Device name
- Cmv-Igm Ifa Test System
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- February 16, 1990
- Decision date
- April 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKQ – Antibody Igm,If, Cytomegalovirus Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
Other 510(k)s with product code LKQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100433 | Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200 CMV Igm Adjustor…LKQ · Traditional | Siemens Healthcare Diagnostics | 05/13/2010SE |
| K972884 | Accurun 146 CMV Igm Positive ControlLKQ · Traditional | Boston Biomedica, Inc. | 08/22/1997SE |
| K933549 | Vidas CMV Igm AssayLKQ · Traditional | Biomerieux Vitek, Inc. | 08/02/1994SE |
| K922580 | Bartels Cytomegalovirus Igm EiaLKQ · Traditional | Baxter Diagnostics, Inc. | 04/08/1993SE |
| K914789 | Elisa CMV IgmLKQ · Traditional | Sclavo, Inc. | 03/04/1992SE |
| K913080 | Opus(R) Anti Cmv-MLKQ · Traditional | Pb Diagnostics, Inc. | 10/28/1991SE |
| K893465 | CMV Igm Antibody Test (Indirect Fluorescent Test)LKQ · Traditional | Immuno Concepts, Inc. | 07/25/1989SE |
| K893466 | CMV Igm Antibody Test (Indirect Enzyme Test)LKQ · Traditional | Immuno Concepts, Inc. | 07/14/1989SE |
| K872881 | Abbott Cmv-M Eia KitLKQ · Traditional | Abbott Laboratories | 05/13/1988SE |
| K872942 | Igm CMV Clin-Elisa(Tm) Test System Number: 5530LKQ · Traditional | Clinical Sciences, Inc. | 01/11/1988SE |
More from Clinical Sciences, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | 08/21/2026SE |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBOBE · Traditional | 05/08/2026SE |
| K250666 | Alegria Flash CTD ScreenLLL · Traditional | 10/22/2025SE |
| K250408 | Alegria Flash ENA ScreenLLL · Traditional | 09/19/2025SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | 05/07/2025SE |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional | 08/31/2023SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | 07/13/2023SE |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | 04/29/2022SE |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
Questions and answers
When was Cmv-Igm Ifa Test System cleared by the FDA?
Cmv-Igm Ifa Test System (K900743) received a 510(k) decision of Substantially Equivalent on April 26, 1990, 69 days after the submission was received.
What is the product code of K900743?
The FDA product code is LKQ – Antibody Igm,If, Cytomegalovirus Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.