Isotypes Human Igg Subclass Eia Kit
FDA 510(k) K920370 · Isotypes, Inc.
510(k) numberK920370
Submission
- Device name
- Isotypes Human Igg Subclass Eia Kit
- Applicant
- Isotypes, Inc.
Newark, DE, US - Received
- January 28, 1992
- Decision date
- March 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGM – Method, Immunodiffusion, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code CGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K915650 | Human Igg Subclass Rid KitCGM · Traditional | Janssen Biochimica | 03/26/1992SE |
| K920006 | Il Test Immunoglobulin G (Igg)CGM · Traditional | Instrumentation Laboratory CO | 03/13/1992SE |
| K920008 | Il Test Immunoglobulin M (Igm)CGM · Traditional | Instrumentation Laboratory CO | 03/11/1992SE |
Questions and answers
When was Isotypes Human Igg Subclass Eia Kit cleared by the FDA?
Isotypes Human Igg Subclass Eia Kit (K920370) received a 510(k) decision of Substantially Equivalent on March 11, 1992, 43 days after the submission was received.
What is the product code of K920370?
The FDA product code is CGM – Method, Immunodiffusion, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.