Biological & Environmental Control Laboratories
Mchenry, IL, US
Biological & Environmental Control Laboratories appears in FDA device records in Mchenry, IL. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Biological & Environmental Control Laboratories carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Lexamedrecall
510(k) clearance history
FDA records hold 20 510(k) clearances for Biological & Environmental Control Laboratories between 1982 and 1997. The busiest year on record is 1985, with 5. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1984 | 4 |
| 1985 | 5 |
| 1986 | 5 |
| 1996 | 4 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971500 | ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER | FPA | Substantially Equivalent | |
| K962802 | SAFE MATE I.V. FLUID DELIVERY SETS | FPA | Substantially Equivalent | |
| K962801 | SAFE MATE I.V. EXTENSION SETS | FPA | Substantially Equivalent | |
| K961328 | BEC SHROUDED PLASTIC CANNULA | FMI | Substantially Equivalent | |
| K961327 | BEC NEEDLELESS INJECTION SITE | FPA | Substantially Equivalent | |
| K863635 | UPDATED STERILE ENDOTRACHEAL BRUSHES | EPE | Substantially Equivalent | |
| K863633 | SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES | LDQ | Substantially Equivalent | |
| K863636 | UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS | Substantially Equivalent | ||
| K863637 | UPDATED STERILE GOWNS, MASKS AND TOWELS | Substantially Equivalent | ||
| K863632 | UPDATED STERILE PROCEDURAL KIT | Substantially Equivalent | ||
| K851851 | STERILE ENDOTRACHEAL BRUSHES | Substantially Equivalent | ||
| K851390 | STERILE GENERAL HOSPITAL SUPPLIES | LDQ | Substantially Equivalent | |
| K851852 | GENERAL HOSPITAL INSTRUMENTS | Substantially Equivalent | ||
| K851853 | STERILE GOWNS, MASKS & TOWELS | Substantially Equivalent | ||
| K842990 | STERILE EYE SURGERY KITS | HOZ | Substantially Equivalent | |
| K844196 | WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT | KME | Substantially Equivalent | |
| K842989 | SHAVE PREP KITS | KME | Substantially Equivalent | |
| K842490 | SKIN SCRUB TRAY STERILE SKIN SCRUB KIT | FRG | Substantially Equivalent | |
| K842579 | B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS | JTR | Substantially Equivalent | |
| K821769 | MICROKNIFE | EMF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1043-2009 | BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose. | Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution. | Terminated | ||
| Z-0787-06 | Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: ''b.e.c. Growth-Chek Microbial Suspensions/Aspergillus niger Derived from ATCC Culture #16404**** Store Under Refrigeration***10mL *Shake Well''. The product is distributed by and/or manufactured by BEC Laboratories, Inc., 705 Front Street, Toledo, OH 43605. | Aspergillus niger microbial suspension, found to be contaminated with yeast, was distributed. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain