BACTIDROP(TM) LACTOPHENOL ANILINE BLUE— 510(k) K913005
Substantially EquivalentRemel Co.
FDA 510(k) clearance K913005 for BACTIDROP(TM) LACTOPHENOL ANILINE BLUE, Substantially Equivalent on 1991-09-16. Applicant: Remel Co.. Device class: 2.
Clearance details
- Applicant
- Remel Co.
- Product code
- Code JIO
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
Recent devices under product code JIO
view all- 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
More clearances from Remel Co.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.