Alfa Wassermann, Inc.
Alfa Wassermann, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2009, with 3 FDA device recalls on record.
Top product codes for Alfa Wassermann, Inc.
FDA recalls by Alfa Wassermann, Inc.
- Z-1529-2014 — Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.
- Z-1530-2014 — Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
- Z-0743-2013 — Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Alfa Wassermann, Inc.
- K091413 — S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
- K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
- K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
- K080073 — S-TEST CREATININE (CRE)
- K063306 — ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
Data sourced from openFDA. This site is unofficial and independent of the FDA.