The following data is part of a premarket notification filed by Packard Instrument Co., Inc. with the FDA for Probe(tm) Models 700 And 1000.
Device ID | K883749 |
510k Number | K883749 |
Device Name: | PROBE(TM) MODELS 700 AND 1000 |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | PACKARD INSTRUMENT CO., INC. 2200 WARRENVILLE RD. Downers Grove, IL 60515 |
Contact | George L Russell |
Correspondent | George L Russell PACKARD INSTRUMENT CO., INC. 2200 WARRENVILLE RD. Downers Grove, IL 60515 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-01 |
Decision Date | 1988-11-10 |