CARBON DIOXIDE REAGENTS
FDA 510(k) clearance K780506 · decided 1978-05-03
Clearance details
- K-number
- K780506
- Device name
- CARBON DIOXIDE REAGENTS
- Applicant
- Gamma Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-30
- Decision date
- 1978-05-03
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- KMS
- Device class
- 2
- Regulation number
- 862.1160
- 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 |
|---|---|---|
| CARBON DIOXIDE (K872886) | Catachem, Inc. | 1987-08-13 |
| AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (K870025) | American Research Products Co. | 1987-03-13 |
| CO2 COLOR REAGENT & CO2 SAMPLE DILUENT (K802162) | Panmed, Inc. | 1980-10-10 |
| REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (K800681) | Diagnostic Solutions, Inc. | 1980-05-30 |
Recalls involving this device
No recalls on record reference this clearance.