The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Staphylase Test.
Device ID | K874303 |
510k Number | K874303 |
Device Name: | STAPHYLASE TEST |
Classification | Staphylococcus Aureus Somatic Antigens |
Applicant | OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
Contact | Ruth Kemp |
Correspondent | Ruth Kemp OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
Product Code | LHT |
CFR Regulation Number | 866.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-20 |
Decision Date | 1987-11-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384013135 | K874303 | 000 |