PROMPT INOCULATION SYSTEM
FDA 510(k) clearance K820299 · decided 1982-03-15
Clearance details
- K-number
- K820299
- Device name
- PROMPT INOCULATION SYSTEM
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1982-02-04
- Decision date
- 1982-03-15
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- LIE
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- White City, OR, 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 |
|---|---|---|
| MicroScan Prompt Inoculation System-D (K221493) | Beckman Coulter, Inc. | 2023-04-05 |
| THE SENSITITRE AIM (K103456) | Trek Diagnostic Systems | 2011-06-22 |
| SENSITITRE AIM (TM) (K110331) | Trek Diagnostic Systems, Ltd. | 2011-04-27 |
| SENSI-CAL AMCO AEPA-1 (K935566) | Radiometer America, Inc. | 1994-03-29 |
| TURBIDOMETRIC STANDARD (K911059) | Scientific Device Laboratory, Inc. | 1991-06-10 |
| DIFCO DIRECTOR INOCULATION SYSTEM (K890339) | Difco Laboratories, Inc. | 1989-02-07 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 1509 recall (Z-1674-2020) | Beckman Coulter Inc. | 2020-04-06 |
| Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D; recall (Z-0247-2007) | Dade Behring, Inc. | 2006-12-05 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |