Elisa CMV Igm
FDA 510(k) K914789 · Sclavo, Inc.
510(k) numberK914789
Submission
- Device name
- Elisa CMV Igm
- Applicant
- Sclavo, Inc.
Wayne, NJ, US - Received
- October 23, 1991
- Decision date
- March 4, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKQ – Antibody Igm,If, Cytomegalovirus Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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|---|---|---|---|
| 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 |
| K913080 | Opus(R) Anti Cmv-MLKQ · Traditional | Pb Diagnostics, Inc. | 10/28/1991SE |
| K900743 | Cmv-Igm Ifa Test SystemLKQ · Traditional | Zeus Scientific, Inc. | 04/26/1990SE |
| 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 |
|---|---|---|
| K914852 | Elisa Toxo IgmLGD · Traditional | 01/23/1992SE |
| K914420 | Elisa Rubella IgmLFX · Traditional | 12/27/1991SE |
| K895943 | Normal and Abnormal Control SeraJJY · Traditional | 12/27/1989SE |
| K895822 | Total Bilirubin L.F.CIG · Traditional | 11/14/1989SE |
| K895847 | Creatinine 340 (Enzymatic)CGX · Traditional | 10/30/1989SE |
| K880199 | Cholinesterase - Acetythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
| K880049 | Cholinesterase - Butyrythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
| K873496 | Atypical CholinesteraseDIH · Traditional | 01/27/1989SE |
| K884035 | Saitron 430 Random Access Chemistry AnalyzerJJE · Traditional | 12/29/1988SE |
| K884649 | Total Iron Binding Capacity TestJQE · Traditional | 12/14/1988SE |
Questions and answers
When was Elisa CMV Igm cleared by the FDA?
Elisa CMV Igm (K914789) received a 510(k) decision of Substantially Equivalent on March 4, 1992, 133 days after the submission was received.
What is the product code of K914789?
The FDA product code is LKQ – Antibody Igm,If, Cytomegalovirus Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.