GLUCAGON RIA MODULE
FDA 510(k) clearance K771948 · decided 1978-01-20
Clearance details
- K-number
- K771948
- Device name
- GLUCAGON RIA MODULE
- Applicant
- Inter Science Institute
- Decision
- Substantially Equivalent
- Date received
- 1977-10-17
- Decision date
- 1978-01-20
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- JME
- Device class
- 1
- Regulation number
- 862.1335
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DOUBLE ANTIBODY GLUCAGON (K893975) | Diagnostic Products Corp. | 1989-10-31 |
| RIA KIT, GLUCOSE (K782143) | Serono Laboratories, Inc. | 1979-02-22 |
Recalls involving this device
No recalls on record reference this clearance.