Alfa Wassermann, Inc.
FDA Regulatory Profile
Alfa Wassermann, Inc. appears in FDA public data with 3 recalls, 9 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1529-2014, Class II) was initiated on March 5, 2014. Its most recent 510(k) clearance was granted on August 14, 2013.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 9
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1529-2014 | Class II | Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitativ | March 5, 2014 |
| Z-1530-2014 | Class II | Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitativ | March 5, 2014 |
| Z-0743-2013 | Class II | Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LL | October 10, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | August 14, 2013 |
| K113382 | ACE ALT REAGENT | July 19, 2012 |
| K113436 | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT | July 12, 2012 |
| K113435 | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE M | July 2, 2012 |
| K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCER | October 26, 2009 |
| K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | September 9, 2009 |
| K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | August 3, 2009 |
| K080073 | S-TEST CREATININE (CRE) | June 30, 2008 |
| K063306 | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CO | April 17, 2007 |