510(k) K101434
- Device
- AUDIT MICROCV PROCALCITONIN LINEARITY
- Applicant
- AALTO SCIENTIFIC LTD.
- 510(k) number
- K101434
- Product code
- MJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-07-22
- Date received
- 2010-05-21
- Regulation
- 862.1660
- Classification name
- Kit, Serological, Positive Control
- Medical specialty
- Clinical Chemistry
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DESSI LYAKOV
- Address
- 1959 Kellogg Ave. Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 2250051
- 3014150341
- 3012963943
- 3011325031
- 3002809144
- 2032682
- 1524213
- 1319681
- 3000308930
- 3007111389
- 3007088335
- 3005333358
- 3031590640
- 3002642396
Source Documents#
Other 510(k) Records For Product Code MJX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K030067 | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS | Ortho-Clinical Diagnostics | 2003-01-17 |
| K974262 | SYSCOS IDC - G, IDC, BSC, IDC - G | Scantibodies Laboratory, Inc. | 1997-12-24 |
| K972986 | ACCURUN 140 RUBELLA IGG POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-10-08 |
| K970100 | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL | Simplicity Diagnostics, Inc. | 1997-03-10 |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | Pb Diagnostic Systems, Inc. | 1994-03-07 |
| K925703 | OPUS SEROLOGY CONTROLS | Pb Diagnostics, Inc. | 1993-04-08 |
Legacy Summary#
summary
FDA Review#
Decision Summary