The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Air Displacement Pipette.
Device ID | K885340 |
510k Number | K885340 |
Device Name: | AIR DISPLACEMENT PIPETTE |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
Contact | Robert K Mcewen |
Correspondent | Robert K Mcewen ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-28 |
Decision Date | 1989-02-14 |