The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Test, Mono., Differential Slide.
Device ID | K760032 |
510k Number | K760032 |
Device Name: | TEST, MONO., DIFFERENTIAL SLIDE |
Classification | Slide Stainer, Contact Type |
Applicant | GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIN |
CFR Regulation Number | 864.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-14 |
Decision Date | 1976-08-03 |