AO-10 AUTOMATED OSMOMETER
FDA 510(k) clearance K843997 · decided 1984-10-31
Clearance details
- K-number
- K843997
- Device name
- AO-10 AUTOMATED OSMOMETER
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-11
- Decision date
- 1984-10-31
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- JJM
- Device class
- 1
- Regulation number
- 862.2730
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Ivyland, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE ADVANCED OSMOMETER (3900) (K965036) | Advanced Instruments, Inc. | 1997-02-20 |
| ADVANCED MICRO-OSMOMETER MODEL 3300 (K962056) | Advanced Instruments, Inc. | 1996-07-11 |
| MODEL 3D3 OSMOMETER (K925970) | Advanced Instruments, Inc. | 1993-07-09 |
| OSMOMETER MODEL 2400 (K911092) | Advanced Instruments, Inc. | 1991-05-22 |
| OSMOMETER MODEL 110 (K873642) | Advanced Instruments, Inc. | 1987-10-20 |
| OSMOTIC PRESSURE AUTO & STAT OM-6010 (K842750) | Kyoto Diagnostics, Inc. | 1984-08-17 |
| WESCOR 5500 VAPOR PRESSURE OSMOMETER (K834214) | Wescor, Inc. | 1984-03-30 |
| COLLOID OSMOMETER 4400 (K834208) | Wescor, Inc. | 1984-03-23 |
| MICRO-SAMPLE OSMOMETER 3M0 (K832783) | Advanced Instruments, Inc. | 1983-11-28 |
| OSMOMETER MODEL OM-6010 (K811179) | Fiske Med Science | 1981-05-15 |
| OSMOMETER MODEL 3W11 (K790611) | Advanced Instruments, Inc. | 1979-06-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THXID-BRAF (P120014/S012) | bioMerieux, Inc. | 2021-12-20 |
| THxID-BRAF kit (P120014/S011) | bioMerieux, Inc. | 2021-03-10 |
| THxID-BRAF assay kit (P120014/S010) | bioMerieux, Inc. | 2020-02-26 |
| THxID BRAF assay kit (P120014/S009) | bioMerieux, Inc. | 2019-08-26 |
| THxID BRAF assay kit (P120014/S008) | bioMerieux, Inc. | 2018-06-27 |
| THxID-BRAF kit (P120014/S007) | bioMerieux, Inc. | 2016-11-22 |
| VIDAS TOTAL PSA (P040008/S013) | bioMerieux, Inc. | 2016-05-31 |
| THXID-BRAF KIT (P120014/S006) | bioMerieux, Inc. | 2016-04-05 |