TOTAL CO2 REAGENT SET
FDA 510(k) clearance K832071 · decided 1983-08-11
Clearance details
- K-number
- K832071
- Device name
- TOTAL CO2 REAGENT SET
- Applicant
- American Research Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-27
- Decision date
- 1983-08-11
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- CIE
- 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 American Research Products Co.
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 |
|---|---|---|
| P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT (K904761) | Instrumentation Laboratory CO | 1990-11-20 |
| MICRO CO2 APPARATUS (K880967) | Hf Scientific, Inc. | 1988-04-28 |
| CO2 REAGENT SET (K864313) | Hf Scientific, Inc. | 1987-03-13 |
| AIRMED SMOKE EVACUATION & FILTER (K820091) | James L. Geraci & Associates, Inc. | 1982-02-24 |
| SERALYZER REFLECTANCE PHOTOMETER/CALIB. (K800524) | Miles Laboratories, Inc. | 1980-04-02 |
| CARBON DIOXIDE ANALYZER (K771610) | Corning Medical & Scientific | 1977-10-07 |
Recalls involving this device
No recalls on record reference this clearance.