Accu-Staph
FDA 510(k) K820347 · Carr-Scarborough Microbiologicals, Inc.
510(k) numberK820347
Submission
- Device name
- Accu-Staph
- Applicant
- Carr-Scarborough Microbiologicals, Inc.
Walker, MI, US - Received
- February 8, 1982
- Decision date
- March 4, 1982
- 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 |
| 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 |
| 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 |
|---|---|---|
| K944554 | Brain Heart Infusion AgarJSO · Traditional | 10/04/1994SE |
| K941985 | Mueller Hinton Agar W/OxacillinJTZ · Traditional | 08/24/1994SE |
| K905472 | Lap DiscsJTO · Traditional | 02/27/1991SE |
| K905666 | M. Cat. Butyrate DiscJTO · Traditional | 02/26/1991SE |
| K891476 | C. Albicans ScreenJXC · Traditional | 04/12/1989SE |
| K882636 | Aln DiscsJTO · Traditional | 02/16/1989SE |
| K882630 | Pro DiscsJTO · Traditional | 02/16/1989SE |
| K863216 | Neis NzyJTO · Traditional | 09/15/1986SE |
| K860301 | Rapid Glutamic Acid Decarboxylase (GDC) MicrotubeJTO · Traditional | 02/06/1986SE |
| K860302 | Pyr DiscsJTO · Traditional | 02/05/1986SE |
Questions and answers
When was Accu-Staph cleared by the FDA?
Accu-Staph (K820347) received a 510(k) decision of Substantially Equivalent on March 4, 1982, 24 days after the submission was received.
What is the product code of K820347?
The FDA product code is LHT – Staphylococcus Aureus Somatic Antigens, a Class I (low risk) device regulated under 21 CFR 866.3700.