K050709 is the FDA 510(k) clearance record for RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367, a class II device, cleared for Wallac OY on 2006-03-08 under FDA product code GKA (Abnormal Hemoglobin Quantitation). FDA records list 24 510(k) clearances for Wallac OY, from 1992-11-30 to 2014-12-15 . As of 2026-09-10 , FDA records show one recall naming K050709.
Clearance record Decision date 2006-03-08 Received 2005-03-18 (355 days to decision) Product code GKA Abnormal Hemoglobin QuantitationRegulation 21 CFR 864.7415 Device class Class II Review panel Hematology Applicant Wallac OY Mustionkatu 6, Turku, FI 510(k) summary Summary PDF ↗ Third party review No
Clearances, product code GKA Trailing 12 months FDA records hold no clearances under product code GKA in the trailing twelve months.
FDA records show no clearances under product code GKA in the twelve months to October 2026. Show the numbers FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
Product code GKA
Z-1208-2022 Class II The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in... Bio-Rad Laboratories, Inc. / initiated 2022-04-07 / 1893 Z-0321-2021 Class II The product did not receive pre-market approval or clearance. Primus Corporation / initiated 2020-10-09 / 97 devices (USA only) Z-0624-2019 Class II lack of 510K Clark Laboratories, Inc. (dba,Trinity Biotech USA) / initiated 2018-11-01 / 463 units Z-0623-2019 Class II lack of 510K Clark Laboratories, Inc. (dba,Trinity Biotech USA) / initiated 2018-11-01 / 216 units Z-0622-2019 Class II lack of 510K Clark Laboratories, Inc. (dba,Trinity Biotech USA) / initiated 2018-11-01 / 252 units Z-0621-2019 Class II lack of 510K Clark Laboratories, Inc. (dba,Trinity Biotech USA) / initiated 2018-11-01 / 372 units
MDM coverage of this record lists here, newest first.
About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
