Aeskulisa Ana HEP-2, Ref 30-7115US
FDA 510(k) K081104 · Aesku Diagnostics
510(k) numberK081104
Submission
- Device name
- Aeskulisa Ana HEP-2, Ref 30-7115US
- Applicant
- Aesku Diagnostics
Wendelsheim, Rheinland, DE - Received
- April 18, 2008
- Decision date
- May 2, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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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|---|---|---|---|
| K210902 | EliA Ro52, EliA Ro60LKJ · Traditional | Phadia AB | 07/27/2022SE |
| K113610 | Ana-Screen with MDSSLKJ · Special | Bio-Rad Laboratories | 07/09/2012SE |
| K082759 | Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia Ro ImmunoassayLKJ · Traditional | Phadia US, Inc. | 04/10/2009SE |
| K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…LKJ · Traditional | Bio-Rad Laboratories, Inc. | 12/20/2004SE |
| 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 |
| K024223 | Liquichek Anti-Rnp Control, Positive, Catalog #116LKJ · Traditional | Bio-Rad | 01/13/2003SE |
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Questions and answers
When was Aeskulisa Ana HEP-2, Ref 30-7115US cleared by the FDA?
Aeskulisa Ana HEP-2, Ref 30-7115US (K081104) received a 510(k) decision of Substantially Equivalent on May 2, 2008, 14 days after the submission was received.
What is the product code of K081104?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.