NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B— 510(k) K071649
Substantially EquivalentWallac OY
FDA 510(k) clearance K071649 for NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B, Substantially Equivalent on 2008-08-07. Applicant: Wallac OY. Device class: 1.
Clearance details
- Applicant
- Wallac OY
- Product code
- Code JIA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1310
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code JIA
view allMore clearances from Wallac OY
view allRecalls naming K071649
K-number listed on FDA's recall record- Z-0688-2013 — NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
- Z-0689-2013 — DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
- Z-0690-2013 — Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071649.
Data sourced from openFDA. This site is unofficial and independent of the FDA.