ISOTYPES HUMAN IGG SUBCLASS EIA KIT
FDA 510(k) clearance K920370 · decided 1992-03-11
Clearance details
- K-number
- K920370
- Device name
- ISOTYPES HUMAN IGG SUBCLASS EIA KIT
- Applicant
- Isotypes, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-28
- Decision date
- 1992-03-11
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- CGM
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HUMAN IGG SUBCLASS RID KIT (K915650) | Janssen Biochimica | 1992-03-26 |
| IL TEST IMMUNOGLOBULIN G (IGG) (K920006) | Instrumentation Laboratory CO | 1992-03-13 |
| IL TEST IMMUNOGLOBULIN M (IGM) (K920008) | Instrumentation Laboratory CO | 1992-03-11 |
Recalls involving this device
No recalls on record reference this clearance.