Anti-Schistosoma Species Kit
FDA 510(k) K842660 · Amico Lab, Inc.
510(k) numberK842660
Submission
- Device name
- Anti-Schistosoma Species Kit
- Applicant
- Amico Lab, Inc.
- Received
- July 10, 1984
- Decision date
- October 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNH – Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3600
- Specialty
- Microbiology
Other 510(k)s with product code GNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K842527 | Amizyme-Schistosoma Spp. Test KitGNH · Traditional | Amico Lab, Inc. | 09/05/1984SE |
More from Amico Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842662 | Anti-Epstein-Barr Virus KitGNP · Traditional | 12/12/1985SE |
| K842663 | Anti-Herpes Simplex Virus Type 1 or 2GQO · Traditional | 12/06/1985SE |
| K842661 | Anti-Cytomegalovirus KitGQI · Traditional | 12/06/1985SE |
| K842531 | Amizyme-Hsv Types 1 & 2 Test KitsGQO · Traditional | 12/06/1985SE |
| K842530 | Amizyme-Ebv Test KitGNP · Traditional | 12/06/1985SE |
| K842529 | Amizyme-Cmv KitGQI · Traditional | 12/06/1985SE |
| K842658 | Anti-Chlamydia Trachomatis KitLJP · Traditional | 10/01/1984SE |
| K842525 | Amizyme-C Trachomatis Test KitLJP · Traditional | 10/01/1984SE |
| K842533 | Amizyme-Andna Test KitLJM · Traditional | 09/20/1984SE |
| K842532 | Amizyme-Ana Test KitLJM · Traditional | 09/20/1984SE |
Questions and answers
When was Anti-Schistosoma Species Kit cleared by the FDA?
Anti-Schistosoma Species Kit (K842660) received a 510(k) decision of Substantially Equivalent on October 30, 1984, 112 days after the submission was received.
What is the product code of K842660?
The FDA product code is GNH – Antigen, Fluorescent Antibody Test, Schistosoma Mansoni, a Class I (low risk) device regulated under 21 CFR 866.3600.