DOUBLE ANTIBODY GLUCAGON
FDA 510(k) clearance K893975 · decided 1989-10-31
Clearance details
- K-number
- K893975
- Device name
- DOUBLE ANTIBODY GLUCAGON
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-02
- Decision date
- 1989-10-31
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- JME
- Device class
- 1
- Regulation number
- 862.1335
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Los Angeles, CA, 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 |
|---|---|---|
| RIA KIT, GLUCOSE (K782143) | Serono Laboratories, Inc. | 1979-02-22 |
| GLUCAGON RIA MODULE (K771948) | Inter Science Institute | 1978-01-20 |
Recalls involving this device
No recalls on record reference this clearance.