American Laboratories Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 1
- Inspections
- 12
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| F-0092-2014 | Class II | Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A | September 30, 2013 |
| F-0096-2014 | Class II | EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C | September 30, 2013 |
| F-0090-2014 | Class II | Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A | September 30, 2013 |
| F-0094-2014 | Class II | PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Pro | September 30, 2013 |
| F-0089-2014 | Class II | Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A | September 30, 2013 |
| F-0093-2014 | Class II | NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber bo | September 30, 2013 |
| F-0095-2014 | Class II | Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product | September 30, 2013 |
| F-0097-2014 | Class II | EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C | September 30, 2013 |
| F-0091-2014 | Class II | Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A | September 30, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K880185 | DUET (CONDOMS) | June 17, 1988 |