Company ยท US
Bio-Analytics Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1986. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CFA | Electrode, Ion Specific, Magnesium | 1 |
| CFD | Sulfophosphovanillin, Colorimetry, Total Lipids | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 |
| CIW | Starch-Dye Bound Polymer, Amylase | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| DKJ | Colorimetry, Salicylate | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JGZ | O-Phthalaldehyde, Urea Nitrogen | 1 |
| JIS | Calibrator, Primary | 1 |
| JQF | Bathophenanthroline, Iron Binding Capacity | 1 |
| LDP | Colorimetry, Acetaminophen | 1 |
| LKZ | Red-Cell Count By Photometry | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 1986 | K861638 | KINETIC ALKALINE PHOSPHATASE REAGENT KIT Bio-Analytics Laboratories, Inc. | CJE |
| Mar 14, 1986 | K860245 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT Bio-Analytics Laboratories, Inc. | JFJ |
| Feb 11, 1986 | K860213 | ALBUMIN REAGENT KIT Bio-Analytics Laboratories, Inc. | CIX |
| May 20, 1985 | K851514 | ULTRA-VIOLET GLUCOSE REAGENT Bio-Analytics Laboratories, Inc. | CFA |
| May 20, 1985 | K851513 | ULTRA-VIOLET BUN REAGENT KIT Bio-Analytics Laboratories, Inc. | CDQ |
| Mar 5, 1985 | K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT Bio-Analytics Laboratories, Inc. | CIW |
| Oct 28, 1983 | K832771 | ERYTHROCYTE TEST Bio-Analytics Laboratories, Inc. | LKZ |
| Sep 12, 1983 | K832567 | ACETAMINOPHEN(PARACETAMOL Bio-Analytics Laboratories, Inc. | LDP |
| Jun 16, 1983 | K831414 | COLORIMETRIC BUN Bio-Analytics Laboratories, Inc. | CDL |
| Jul 20, 1982 | K821934 | BIO-CAL OPERATION CHECK KIT Bio-Analytics Laboratories, Inc. | JIS |
| Mar 25, 1982 | K813431 | SALICYLATES Bio-Analytics Laboratories, Inc. | DKJ |
| Dec 31, 1981 | K813469 | LIPID PROFILE Bio-Analytics Laboratories, Inc. | CFD |
| Feb 26, 1981 | K810087 | UREA NITROGEN, KINETIC Bio-Analytics Laboratories, Inc. | JGZ |
| Jan 28, 1981 | K810088 | URIC ACID (TPTZ) COLORINMETRIC Bio-Analytics Laboratories, Inc. | CDH |
| Jan 28, 1981 | K810086 | IRON & TICB Bio-Analytics Laboratories, Inc. | JQF |
| Jan 28, 1981 | K810085 | IRON KIT Bio-Analytics Laboratories, Inc. | CFM |
| Jan 28, 1981 | K810083 | LDH-L LIQUID ENZYMATIC, KINETIC KIT Bio-Analytics Laboratories, Inc. | CFJ |
| Jan 26, 1981 | K810084 | MAGNESIUM KIT Bio-Analytics Laboratories, Inc. | JGJ |
| Jan 26, 1981 | K810082 | ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT Bio-Analytics Laboratories, Inc. | CJE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||