G7 AUTOMATED HPLC ANALYZER— 510(k) K011434
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K011434 for G7 AUTOMATED HPLC ANALYZER, Substantially Equivalent on 2001-09-18. Applicant: Tosoh Medics, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Medics, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
Recent devices under product code LCP
view allMore clearances from Tosoh Medics, Inc.
view allRecalls naming K011434
K-number listed on FDA's recall record- Z-2066-2015 — G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
- Z-1075-2013 — G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011434.
Data sourced from openFDA. This site is unofficial and independent of the FDA.