The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Kryorack/4.
Device ID | K780757 |
510k Number | K780757 |
Device Name: | KRYORACK/4 |
Classification | Regulator, Temperature |
Applicant | STRECK LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JRR |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-08 |
Decision Date | 1978-06-06 |