MULTICHECK
FDA 510(k) clearance K952725 · decided 1996-02-20
Clearance details
- K-number
- K952725
- Device name
- MULTICHECK
- Applicant
- Radiometer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-14
- Decision date
- 1996-02-20
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- GLY
- Device class
- 2
- Regulation number
- 864.7500
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Westlake, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Radiometer America
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 |
|---|---|---|
| HEMONIR TM (K050014) | Nir Diagnostics, Inc. | 2005-05-05 |
| STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR (K993104) | Nova Biomedical Corp. | 1999-12-02 |
| NOVA CO-OXIMETER ANALYZER (K955013) | Nova Biomedical Corp. | 1996-04-25 |
| AVL MODEL 912 CO-OXYLITE (K895466) | Avl Scientific Corp. | 1989-11-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S004) | Radiometer America, Inc. | 1986-02-21 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S003) | Radiometer America, Inc. | 1985-02-22 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S002) | Radiometer America, Inc. | 1984-03-01 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S001) | Radiometer America, Inc. | 1981-09-21 |