Product code JIH— Clinical Toxicology
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
- Classification name
- Flame Photometry, Lithium
- Device class
- Class 2
- Regulation
- 21 CFR 862.3560
- Advisory panel
- Clinical Toxicology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code JIH
FDA has cleared devices under product code JIH between 1977 and 2005, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 2003
- 2001
- 1994
- 1993
- 1992
- 1989
- 1983
- 1980
- 1977
Top applicants under product code JIH
Recent clearances under product code JIH
- K050338 — MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
- K031579 — INSTAREAD LITHIUM SYSTEM
- K011033 — DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
- K934106 — KODAK EKTACHEM DTSC II SLIDES (LI)
- K924488 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)
- K921403 — MODEL 654 ANALYZER
- K895465 — AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
- K894328 — TDX(R) LITES(TM) LITHIUM
- K830636 — POTASSIUM DILUENT
- K800039 — LITHIUM DILUENT (1500 MM/E)
- K771303 — FLAME PHOTOMETER MODEL 460
- K770824 — FLAME PHOTOMETER MOLEL 4600, KDA
Data sourced from openFDA. This site is unofficial and independent of the FDA.