Sero-Stat R II Staphylococcus Test
FDA 510(k) K863025 · Scott Laboratories, Inc.
510(k) numberK863025
Submission
- Device name
- Sero-Stat R II Staphylococcus Test
- Applicant
- Scott Laboratories, Inc.
Fiskeville, RI, US - Received
- August 11, 1986
- Decision date
- September 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LHT – Staphylococcus Aureus Somatic Antigens
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3700
- Specialty
- Microbiology
Other 510(k)s with product code LHT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874303 | Staphylase TestLHT · Traditional | Oxoid U.S.A., Inc. | 11/06/1987SE |
| 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 |
More from Dutchland Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880694 | B. Cat ConfirmJTO · Traditional | 06/16/1988SE |
| K874933 | Mug-Indole DiscJTO · Traditional | 01/05/1988SE |
| K874662 | Myco-Fluor Reagent a & BJTS · Traditional | 11/25/1987SE |
| K873509 | Identicult-BlJTO · Traditional | 10/15/1987SE |
| K871238 | AnabagKZJ · Traditional | 04/03/1987SE |
| K852869 | Selecticult-ChlamydiaLKH · Traditional | 09/19/1985SE |
| K852832 | Identicult-NeisseriaJTO · Traditional | 07/19/1985SE |
| K852666 | Identicult-AeJTO · Traditional | 07/15/1985SE |
| K841680 | Scott Selecticult-Hsv Isolation &GQL · Traditional | 10/30/1984SE |
| K811098 | Sero-Stat Staphylococcus TestJWX · Traditional | 05/05/1981SE |
Questions and answers
When was Sero-Stat R II Staphylococcus Test cleared by the FDA?
Sero-Stat R II Staphylococcus Test (K863025) received a 510(k) decision of Substantially Equivalent on September 15, 1986, 35 days after the submission was received.
What is the product code of K863025?
The FDA product code is LHT – Staphylococcus Aureus Somatic Antigens, a Class I (low risk) device regulated under 21 CFR 866.3700.