Panels › Clinical Chemistry › Product code JJM · Class 1
Osmometer For Clinical Use
Regulation 862.2730
0510(k)s in 12 months (12 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in JJM
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Instruments, Inc. | 7 | 1 |
| Wescor, Inc. | 2 | 2 |
| bioMerieux, Inc. | 1 | 0 |
| Fiske Med Science | 1 | 0 |
| Kyoto Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2024 | Advanced Instruments, LLC OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine.
Model/Catalog Number: OsmoPRO MAX
Soft Open, Classified |
JJM | None listed |
| Mar 27, 2008 | Wescor, Inc Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321. Terminated |
JJM | K834208 |
| Mar 27, 2008 | Wescor, Inc Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321. Terminated |
JJM | K834208 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.