ETI-MAX 3000
FDA 510(k) clearance K052794 · decided 2006-03-31
Clearance details
- K-number
- K052794
- Device name
- ETI-MAX 3000
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-03
- Decision date
- 2006-03-31
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- JJF
- Device class
- 1
- Regulation number
- 862.2170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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| WINMAX SOFTWARE SYSTEMS (K965103) | Diagnostic Products Corp. | 1997-05-09 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021) | DiaSorin, Inc. | 2025-10-10 |