Staphylococcus Aureus Somatic Antigens
FDA product code LHT · Class I (low risk) · 21 CFR 866.3700 · Microbiology
13510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874303 | Staphylase TestLHT · Traditional | Oxoid U.S.A., Inc. | 11/06/1987SE |
| K863025 | Sero-Stat R II Staphylococcus TestLHT · Traditional | Scott Laboratories, Inc. | 09/15/1986SE |
| K820683 | Staphylococcus Latex Agglutination KitLHT · Traditional | American Scientific Products | 04/14/1982SE |
| K820531 | Endo-Staph Teichoic Acid Antibody KitLHT · Traditional | Meridian Diagnostics, Inc. | 04/14/1982SE |
| K820347 | Accu-StaphLHT · Traditional | Carr-Scarborough Microbiologicals, Inc. | 03/04/1982SE |
| K812434 | Diagnostic Kits & Kit ComponentsLHT · Traditional | Diagnostica, Inc. | 09/23/1981SE |
| K812376 | Sheep Blood in Alsever's, Citr., DefibrLHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
| K812375 | Baby Chick Blood in Alsever'sLHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
| K812374 | Adult Chicken Blood in Alsever's, C., D.LHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
| K812373 | Rabbit Blood in Alsever's, Citr., DefibrLHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
| K812372 | Guinea Pig Blood in Alsever's, Cit., DefLHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
| K812368 | Rat Blood in Alsever's, CitratedLHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |
| K812367 | Goose Blood in Alsever's, Citrated (Acd)LHT · Traditional | Dutchland Laboratories, Inc. | 09/09/1981SE |