The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Microscope Slides.
Device ID | K862112 |
510k Number | K862112 |
Device Name: | MICROSCOPE SLIDES |
Classification | Device, General Purpose, Microbiology, Diagnostic |
Applicant | ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
Contact | Piyush M Shah |
Correspondent | Piyush M Shah ABCO DEALERS, INC. P.O. BOX 17587 6637 NORTH SIDNEY PLACE Milwaukee, WI 53217 |
Product Code | LIB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-03 |
Decision Date | 1986-06-13 |