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 |