The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Wescor Stain Pack For Model 7100 Aerospray Slide S.
Device ID | K852138 |
510k Number | K852138 |
Device Name: | WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S |
Classification | Wright's Stain |
Applicant | CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim, CA 92807 |
Contact | Anthony Falkowski |
Correspondent | Anthony Falkowski CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim, CA 92807 |
Product Code | IAF |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-16 |
Decision Date | 1985-06-13 |