SENSITITRE AUTO ID PLATE AP80
FDA 510(k) clearance K890057 · decided 1989-06-09
Clearance details
- K-number
- K890057
- Device name
- SENSITITRE AUTO ID PLATE AP80
- Applicant
- Radiometer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-06
- Decision date
- 1989-06-09
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- LQM
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| ROCHE OXI/FERM II (K923313) | Roche Diagnostic Systems, Inc. | 1993-04-05 |
| VITEK RAPID CALL-GRAM NEGATIV IDENT CARD (K925915) | Biomerieux Vitek, Inc. | 1993-03-23 |
| SCEPTOR IDENTIFICATION SYSTEM (K912897) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-28 |
| VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (K911429) | Vitek Systems, Inc. | 1991-06-24 |
| GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (K862642) | American Micro Scan | 1986-09-11 |
| PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM (K851528) | Pasco Laboratories, Inc. | 1985-07-15 |
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 |