Bio-Analytics Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K861638 | KINETIC ALKALINE PHOSPHATASE REAGENT KIT | May 29, 1986 |
| K860245 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | March 14, 1986 |
| K860213 | ALBUMIN REAGENT KIT | February 11, 1986 |
| K851513 | ULTRA-VIOLET BUN REAGENT KIT | May 20, 1985 |
| K851514 | ULTRA-VIOLET GLUCOSE REAGENT | May 20, 1985 |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | March 5, 1985 |
| K832771 | ERYTHROCYTE TEST | October 28, 1983 |
| K832567 | ACETAMINOPHEN(PARACETAMOL | September 12, 1983 |
| K831414 | COLORIMETRIC BUN | June 16, 1983 |
| K821934 | BIO-CAL OPERATION CHECK KIT | July 20, 1982 |
| K813431 | SALICYLATES | March 25, 1982 |
| K813469 | LIPID PROFILE | December 31, 1981 |
| K810087 | UREA NITROGEN, KINETIC | February 26, 1981 |
| K810088 | URIC ACID (TPTZ) COLORINMETRIC | January 28, 1981 |
| K810085 | IRON KIT | January 28, 1981 |
| K810086 | IRON & TICB | January 28, 1981 |
| K810083 | LDH-L LIQUID ENZYMATIC, KINETIC KIT | January 28, 1981 |
| K810084 | MAGNESIUM KIT | January 26, 1981 |
| K810082 | ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT | January 26, 1981 |