The following data is part of a premarket notification filed by Biological & Environmental Control Laboratories with the FDA for B.e.c. Growth Chek Microbial Suspensions.
| Device ID | K842579 |
| 510k Number | K842579 |
| Device Name: | B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS |
| Classification | Kit, Quality Control For Culture Media |
| Applicant | BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JTR |
| CFR Regulation Number | 866.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-03 |
| Decision Date | 1984-07-27 |