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 |