PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM
FDA 510(k) clearance K851528 · decided 1985-07-15
Clearance details
- K-number
- K851528
- Device name
- PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM
- Applicant
- Pasco Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-18
- Decision date
- 1985-07-15
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- LQM
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Wheat Ridge, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pasco Laboratories
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 |
| SENSITITRE AUTO ID PLATE AP80 (K890057) | Radiometer America, Inc. | 1989-06-09 |
| GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (K862642) | American Micro Scan | 1986-09-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC ANTIBIOTIC TEST PANELS (N50494/S006) | Pasco Laboratories, Inc. | 1983-11-02 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S011) | Pasco Laboratories, Inc. | 1983-07-25 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S010) | Pasco Laboratories, Inc. | 1983-07-08 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S008) | Pasco Laboratories, Inc. | 1982-12-22 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S009) | Pasco Laboratories, Inc. | 1982-12-01 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S007) | Pasco Laboratories, Inc. | 1982-09-03 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S005) | Pasco Laboratories, Inc. | 1982-06-30 |
| MIC ANTIBIOTIC TEST PANELS (N50494/S004) | Pasco Laboratories, Inc. | 1982-03-12 |