The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Protect T.m..
Device ID | K871121 |
510k Number | K871121 |
Device Name: | PROTECT T.M. |
Classification | Kit, Quality Control For Culture Media |
Applicant | PRO-LAB, INC. 705 PROGRESS AVE UNIT 3A Scarborough Ont, CA |
Contact | Lynn Rae |
Correspondent | Lynn Rae PRO-LAB, INC. 705 PROGRESS AVE UNIT 3A Scarborough Ont, CA |
Product Code | JTR |
CFR Regulation Number | 866.2480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-19 |
Decision Date | 1987-04-14 |