Leap Le Test Kit
FDA 510(k) K842484 · Cooper Biomedical, Inc.
510(k) numberK842484
Submission
- Device name
- Leap Le Test Kit
- Applicant
- Cooper Biomedical, Inc.
Mchenry, IL, US - Received
- June 25, 1984
- Decision date
- July 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K082759 | Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia Ro ImmunoassayLKJ · Traditional | Phadia US, Inc. | 04/10/2009SE |
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| K042416 | Athena Multi-Lyte Ana-Ii Test SystemLKJ · Special | Zeus Scientific, Inc. | 10/08/2004SE |
| K034013 | Reaads Dsdna Quantitative Test Kit, Model 022-001LKJ · Special | Corgenix, Inc. | 01/08/2004SE |
| K030775 | Auto I.D. JO-1, SCL-70 & Pcna Positive Control SerumLKJ · Abbreviated | Immuno Concepts, N.A. , Ltd. | 05/12/2003SE |
| K024232 | Liquichek Anti-Ss-B Control, Positive, Catalog #113LKJ · Traditional | Bio-Rad | 01/17/2003SE |
| K024218 | Liquichek Anti-Ss-A Control, Positive, Catalog #114LKJ · Traditional | Bio-Rad | 01/17/2003SE |
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Questions and answers
When was Leap Le Test Kit cleared by the FDA?
Leap Le Test Kit (K842484) received a 510(k) decision of Substantially Equivalent on July 11, 1984, 16 days after the submission was received.
What is the product code of K842484?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.