MICROBIOLOGICAL TRAY READER-MANUAL
FDA 510(k) clearance K842947 · decided 1984-09-14
Clearance details
- K-number
- K842947
- Device name
- MICROBIOLOGICAL TRAY READER-MANUAL
- Applicant
- American Micro Scan
- Decision
- Substantially Equivalent
- Date received
- 1984-07-26
- Decision date
- 1984-09-14
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- JJQ
- Device class
- 1
- Regulation number
- 862.2300
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (K013371) | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 |
| DIGENE DML 2000 MICROPLATE LUMINOMETER (K980120) | Digene Corp. | 1998-02-06 |
| ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (K973938) | Sfri, Inc. | 1998-02-04 |
| STAT TRACKS (K974762) | Awareness Technology, Inc. | 1998-01-28 |
| ANTHOS PHACTS VERSION MICROPLATE READER (K962113) | Columbia Bioscience, Inc. | 1996-11-05 |
| CBI 7520 READER (K961183) | Columbia Bioscience, Inc. | 1996-08-02 |
| ORIGEN ANALYZER (K962166) | Igen, Inc. | 1996-07-31 |
| ANTHOS 2010 READER (K955077) | Anthos Labtec, Inc. | 1995-12-04 |
| ELX808 AUTOMATED MICROPLATE READERS (K953710) | Bio-Tek Instruments, Inc. | 1995-10-25 |
| ELX800UV (K953572) | Bio-Tek Instruments, Inc. | 1995-10-19 |
| BILI-METER (K953005) | Olympic Medical Corp. | 1995-09-28 |
| 5STRATEC SL 300 LIA-MAT (K950029) | Nichols Institute Diagnostics | 1995-08-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC PANELS (N62160/S013) | American Micro Scan | 1985-03-05 |
| MIC PANELS (N62160/S011) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S012) | American Micro Scan | 1984-01-30 |
| MIC PANELS (N62160/S010) | American Micro Scan | 1983-10-12 |
| MIC PANELS (N62160/S009) | American Micro Scan | 1983-09-28 |
| MIC PANELS (N62160/S008) | American Micro Scan | 1983-08-10 |
| MIC PANELS (N62160/S007) | American Micro Scan | 1983-02-03 |
| MIC PANELS (N62160/S006) | American Micro Scan | 1982-11-18 |