MICRODILUTION IDENTIFICATION PANELS
FDA 510(k) clearance K864674 · decided 1987-01-05
Clearance details
- K-number
- K864674
- Device name
- MICRODILUTION IDENTIFICATION PANELS
- Applicant
- American Micro Scan
- Decision
- Substantially Equivalent
- Date received
- 1986-12-02
- Decision date
- 1987-01-05
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- JSE
- Device class
- 1
- Regulation number
- 866.2320
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- West Sacramento, CA, 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 |
|---|---|---|
| MLX MICROTITER PLATE LUMINOMETER (K962265) | Dynatech Laboratories, Inc. | 1996-07-25 |
| X-ACT LDC/IND (K883996) | Pro-Lab, Inc. | 1988-10-12 |
| X-ACT UREA/TDA (K883995) | Pro-Lab, Inc. | 1988-10-12 |
| MRVP BROTH (K880116) | Hardy Media | 1988-03-31 |
| MIL MEDIUM (K880133) | Hardy Media | 1988-03-31 |
| KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (K874537) | Lakewood Biochemical Co., Inc. | 1987-11-20 |
| CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES (K871096) | bioMerieux, Inc. | 1987-04-03 |
| BIOTIS LITMUS MILK (K862393) | Otisville Biotech, Inc. | 1986-07-03 |
| BIOTIS TSI (K860413) | Otisville Biotech, Inc. | 1986-02-24 |
| BIOTIS ORNITHINE INDOLE MOTILITY MEDIA (K860414) | Otisville Biotech, Inc. | 1986-02-24 |
| BIOTIS SIM MEDIUM (K860412) | Otisville Biotech, Inc. | 1986-02-24 |
| BIOTIS SIMMON CITRATE AGAR (K860415) | Otisville Biotech, Inc. | 1986-02-24 |
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 |