GEN-PROBE PAL LUMINOMETER
FDA 510(k) clearance K903911 · decided 1990-10-04
Clearance details
- K-number
- K903911
- Device name
- GEN-PROBE PAL LUMINOMETER
- Applicant
- Gen-Probe, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-24
- Decision date
- 1990-10-04
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JJQ
- Device class
- 1
- Regulation number
- 862.2300
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (K013371) | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 |
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| ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (K973938) | Sfri, Inc. | 1998-02-04 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S019) | Gen-Probe, Inc. | 2012-12-05 |
| AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST (P940034/S018) | Gen-Probe, Inc. | 2010-04-23 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD) (P940034/S017) | Gen-Probe, Inc. | 2007-07-18 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S016) | Gen-Probe, Inc. | 2004-10-08 |
| GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S015) | Gen-Probe, Inc. | 2004-02-10 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST) (P940034/S013) | Gen-Probe, Inc. | 2002-01-25 |
| GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S012) | Gen-Probe, Inc. | 2001-08-30 |
| GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S011) | Gen-Probe, Inc. | 2000-11-21 |