510(k) K843997
- Device
- Ao-10 Automated Osmometer
- Applicant
- BIO MERIEUX, INC.
- 510(k) number
- K843997
- Product code
- JJM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-31
- Date received
- 1984-10-11
- Regulation
- 862.2730
- Classification name
- Osmometer For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM A KOONTZ
- Address
- Northhampton Industrial Park 75 Steam Whistle Dr. Ivyland PA US 18974 18974
FDA Registration Numbers#
- 3016648458
- 3008305513
- 3043138885
- 3030446844
- 3043088937
- 1217058
- 1250003
- 1717966
- 3009155756
- 3003591759
- 3027645317
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JJM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K965036 | THE ADVANCED OSMOMETER (3900) | Advanced Instruments, Inc. | 1997-02-20 |
| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | Advanced Instruments, Inc. | 1996-07-11 |
| K925970 | MODEL 3D3 OSMOMETER | Advanced Instruments, Inc. | 1993-07-09 |
| K911092 | OSMOMETER MODEL 2400 | Advanced Instruments, Inc. | 1991-05-22 |
| K873642 | OSMOMETER MODEL 110 | Advanced Instruments, Inc. | 1987-10-20 |
| K842750 | OSMOTIC PRESSURE AUTO & STAT OM-6010 | Kyoto Diagnostics, Inc. | 1984-08-17 |
| K834214 | WESCOR 5500 VAPOR PRESSURE OSMOMETER | Wescor, Inc. | 1984-03-30 |
| K834208 | COLLOID OSMOMETER 4400 | Wescor, Inc. | 1984-03-23 |
| K832783 | MICRO-SAMPLE OSMOMETER 3M0 | Advanced Instruments, Inc. | 1983-11-28 |
| K811179 | OSMOMETER MODEL OM-6010 | Fiske Med Science | 1981-05-15 |
| K790611 | OSMOMETER MODEL 3W11 | Advanced Instruments, Inc. | 1979-06-15 |