CHEM-LINK DATA BASE MANAGER
FDA 510(k) clearance K912413 · decided 1991-07-01
Clearance details
- K-number
- K912413
- Device name
- CHEM-LINK DATA BASE MANAGER
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-31
- Decision date
- 1991-07-01
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- JJQ
- Device class
- 1
- Regulation number
- 862.2300
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| STAT TRACKS (K974762) | Awareness Technology, Inc. | 1998-01-28 |
| ANTHOS PHACTS VERSION MICROPLATE READER (K962113) | Columbia Bioscience, Inc. | 1996-11-05 |
| CBI 7520 READER (K961183) | Columbia Bioscience, Inc. | 1996-08-02 |
| ORIGEN ANALYZER (K962166) | Igen, Inc. | 1996-07-31 |
| ANTHOS 2010 READER (K955077) | Anthos Labtec, Inc. | 1995-12-04 |
| ELX808 AUTOMATED MICROPLATE READERS (K953710) | Bio-Tek Instruments, Inc. | 1995-10-25 |
| ELX800UV (K953572) | Bio-Tek Instruments, Inc. | 1995-10-19 |
| BILI-METER (K953005) | Olympic Medical Corp. | 1995-09-28 |
| 5STRATEC SL 300 LIA-MAT (K950029) | Nichols Institute Diagnostics | 1995-08-02 |
Recalls involving this device
No recalls on record reference this clearance.