Bio-Analytics Laboratories, Inc.
Mchenry, IL, US
Bio-Analytics Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Bio-Analytics Laboratories, Inc. between 1981 and 1986. The busiest year on record is 1981, with 8. The most recent is 1986, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 8 |
| 1982 | 2 |
| 1983 | 3 |
| 1985 | 3 |
| 1986 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K861638 | KINETIC ALKALINE PHOSPHATASE REAGENT KIT | CJE | Substantially Equivalent | |
| K860245 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | JFJ | Substantially Equivalent | |
| K860213 | ALBUMIN REAGENT KIT | CIX | Substantially Equivalent | |
| K851514 | ULTRA-VIOLET GLUCOSE REAGENT | CFA | Substantially Equivalent | |
| K851513 | ULTRA-VIOLET BUN REAGENT KIT | CDQ | Substantially Equivalent | |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | CIW | Substantially Equivalent | |
| K832771 | ERYTHROCYTE TEST | LKZ | Substantially Equivalent | |
| K832567 | ACETAMINOPHEN(PARACETAMOL | LDP | Substantially Equivalent | |
| K831414 | COLORIMETRIC BUN | CDL | Substantially Equivalent | |
| K821934 | BIO-CAL OPERATION CHECK KIT | JIS | Substantially Equivalent | |
| K813431 | SALICYLATES | DKJ | Substantially Equivalent | |
| K813469 | LIPID PROFILE | CFD | Substantially Equivalent | |
| K810087 | UREA NITROGEN, KINETIC | JGZ | Substantially Equivalent | |
| K810088 | URIC ACID (TPTZ) COLORINMETRIC | CDH | Substantially Equivalent | |
| K810086 | IRON & TICB | JQF | Substantially Equivalent | |
| K810085 | IRON KIT | CFM | Substantially Equivalent | |
| K810083 | LDH-L LIQUID ENZYMATIC, KINETIC KIT | CFJ | Substantially Equivalent | |
| K810084 | MAGNESIUM KIT | JGJ | Substantially Equivalent | |
| K810082 | ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT | CJE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDHAcid, Uric, Phosphotungstate Reduction
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)
- JQFBathophenanthroline, Iron Binding Capacity
- CDLBerthelot Indophenol, Urea Nitrogen
- CIXBromcresol Green Dye-Binding, Albumin
- JISCalibrator, Primary
- JFJCatalytic Methods, Amylase
- LDPColorimetry, Acetaminophen
- DKJColorimetry, Salicylate
- CFAElectrode, Ion Specific, Magnesium
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JGZO-Phthalaldehyde, Urea Nitrogen
- JGJPhotometric Method, Magnesium
- LKZRed-Cell Count By Photometry
- CIWStarch-Dye Bound Polymer, Amylase
- CFDSulfophosphovanillin, Colorimetry, Total Lipids
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain