CO2 COLOR REAGENT & CO2 SAMPLE DILUENT
FDA 510(k) clearance K802162 · decided 1980-10-10
Clearance details
- K-number
- K802162
- Device name
- CO2 COLOR REAGENT & CO2 SAMPLE DILUENT
- Applicant
- Panmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-08
- Decision date
- 1980-10-10
- Days to decision
- 32 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
+ Add to Predicate Builder ◉ Watch Panmed
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (K800681) | Diagnostic Solutions, Inc. | 1980-05-30 |
| CARBON DIOXIDE REAGENTS (K780506) | Gamma Enterprises, Inc. | 1978-05-03 |
Recalls involving this device
No recalls on record reference this clearance.