Product code JIO— Hematology
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
- Classification name
- Blood, Occult, Colorimetric, In Urine
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code JIO
FDA has cleared devices under product code JIO between 1989 and 2024, filed by 10 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
- 2024
- 2012
- 2009
- 2004
- 2003
- 1992
- 1991
- 1989
Top applicants under product code JIO
Recent clearances under product code JIO
- K232317 — UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
- K111999 — HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
- K111221 — MISSION U500 URINE ANALYZER
- K082811 — URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
- K083724 — WIENER LAB. URINE STRIP 10 AND 11
- K040703 — URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
- K023297 — URS-1B (BLOOD TEST)
- K921495 — DIA STRIPS SYSTEM, MODIFIED
- K913005 — BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
- K905396 — HEMASTIX REAGENT STRIPS
- K893894 — CHARISE CHARLES REAGENT BLOOD STRIPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.