HEMOGLOBINOMETER
FDA 510(k) clearance K832288 · decided 1983-09-01
Clearance details
- K-number
- K832288
- Device name
- HEMOGLOBINOMETER
- Applicant
- Mallinckrodt Critical Care
- Decision
- Substantially Equivalent
- Date received
- 1983-07-13
- Decision date
- 1983-09-01
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- KMG
- Device class
- 2
- Regulation number
- 880.6710
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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 |
|---|---|---|
| REMEDY MODEL 2Z12 (K012029) | Apollo Corp. | 2001-12-31 |
| LANCER HEMOGLOBIN ANALYZER REAGENTS (K831253) | Sherwood Medical Co. | 1983-05-09 |
| AQUANOMICS, #HHU100 (K813049) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, #SP36SF (K813045) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, #MP2SF (K813048) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, #MP4SF (K813050) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, MINI 60L (K813047) | Cooper-Hewitt Electric Co. | 1981-12-02 |
| AQUANOMICS, #HHU60 (K813046) | Cooper-Hewitt Electric Co. | 1981-12-02 |
Recalls involving this device
No recalls on record reference this clearance.