Amizyme-Schistosoma Spp. Test Kit
FDA 510(k) K842527 · Amico Lab, Inc.
510(k) numberK842527
Submission
- Device name
- Amizyme-Schistosoma Spp. Test Kit
- Applicant
- Amico Lab, Inc.
Mchenry, IL, US - Received
- June 28, 1984
- Decision date
- September 5, 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 |
|---|---|---|---|
| K842660 | Anti-Schistosoma Species KitGNH · Traditional | Amico Lab, Inc. | 10/30/1984SE |
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 |
| K842660 | Anti-Schistosoma Species KitGNH · Traditional | 10/30/1984SE |
| 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 |
Questions and answers
When was Amizyme-Schistosoma Spp. Test Kit cleared by the FDA?
Amizyme-Schistosoma Spp. Test Kit (K842527) received a 510(k) decision of Substantially Equivalent on September 5, 1984, 69 days after the submission was received.
What is the product code of K842527?
The FDA product code is GNH – Antigen, Fluorescent Antibody Test, Schistosoma Mansoni, a Class I (low risk) device regulated under 21 CFR 866.3600.