Human Igg Subclass Rid Kit
FDA 510(k) K915650 · Janssen Biochimica
510(k) numberK915650
Submission
- Device name
- Human Igg Subclass Rid Kit
- Applicant
- Janssen Biochimica
Piscataway, NJ, US - Received
- December 18, 1991
- Decision date
- March 26, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K920006 | Il Test Immunoglobulin G (Igg)CGM · Traditional | Instrumentation Laboratory CO | 03/13/1992SE |
| K920370 | Isotypes Human Igg Subclass Eia KitCGM · Traditional | Isotypes, Inc. | 03/11/1992SE |
| K920008 | Il Test Immunoglobulin M (Igm)CGM · Traditional | Instrumentation Laboratory CO | 03/11/1992SE |
Questions and answers
When was Human Igg Subclass Rid Kit cleared by the FDA?
Human Igg Subclass Rid Kit (K915650) received a 510(k) decision of Substantially Equivalent on March 26, 1992, 99 days after the submission was received.
What is the product code of K915650?
The FDA product code is CGM – Method, Immunodiffusion, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.