Panels › Clinical Toxicology › Product code JIH · Class 2
Flame Photometry, Lithium
Regulation 862.3560
0510(k)s in 12 months (12 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JIH
| Company | 510(k)s | Recalls |
|---|---|---|
| Eastman Kodak Company | 2 | 0 |
| Ortho-Clinical Diagnostics | 0 | 2 |
| Abbott Laboratories | 1 | 0 |
| Akers Biosciences, Inc. | 1 | 0 |
| Akers Laboratories, Inc. | 1 | 0 |
| American Monitor Corp. | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Ciba Corning Diagnostics Corp. | 1 | 0 |
| Corning Medical & Scientific | 1 | 0 |
| Dade Behring, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2005 | K050338 | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM Akers Biosciences, Inc. | JIH |
| Dec 19, 2003 | K031579 | INSTAREAD LITHIUM SYSTEM Akers Laboratories, Inc. | JIH |
| Jun 7, 2001 | K011033 | DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 Dade Behring, Inc. | JIH |
| Apr 25, 1994 | K934106 | KODAK EKTACHEM DTSC II SLIDES (LI) Eastman Kodak Company | JIH |
| Jan 26, 1993 | K924488 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) Eastman Kodak Company | JIH |
| Jul 30, 1992 | K921403 | MODEL 654 ANALYZER Ciba Corning Diagnostics Corp. | JIH |
| Dec 27, 1989 | K895465 | AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE Baxter Healthcare Corp | JIH |
| Nov 13, 1989 | K894328 | TDX(R) LITES(TM) LITHIUM Abbott Laboratories | JIH |
| Apr 5, 1983 | K830636 | POTASSIUM DILUENT Shaban Mfg. Co. | JIH |
| Jan 21, 1980 | K800039 | LITHIUM DILUENT (1500 MM/E) Gilford Diagnostics | JIH |
| Aug 22, 1977 | K771303 | FLAME PHOTOMETER MODEL 460 Corning Medical & Scientific | JIH |
| Jul 15, 1977 | K770824 | FLAME PHOTOMETER MOLEL 4600, KDA American Monitor Corp. | JIH |
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