The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Oxoid Signal Blood Culture System.
Device ID | K862946 |
510k Number | K862946 |
Device Name: | OXOID SIGNAL BLOOD CULTURE SYSTEM |
Classification | Culture Media, Non-selective And Non-differential |
Applicant | OXOID U.S.A., INC. WADE RD. BASINGSTROKE Hampshire Rg 24 Op, GB |
Contact | E. Y Bridson |
Correspondent | E. Y Bridson OXOID U.S.A., INC. WADE RD. BASINGSTROKE Hampshire Rg 24 Op, GB |
Product Code | JSG |
CFR Regulation Number | 866.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-05 |
Decision Date | 1986-11-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384013623 | K862946 | 000 |