MIC-CONCEPT SYSTEM
FDA 510(k) clearance K852613 · decided 1985-09-20
Clearance details
- K-number
- K852613
- Device name
- MIC-CONCEPT SYSTEM
- Applicant
- Microtech Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-19
- Decision date
- 1985-09-20
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- LTW
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Aurora, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Microtech Medical Systems
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 |
|---|---|---|
| PRECEPT CEFOPERAZONE (K853596) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT CEFTRIAXONE (K853273) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT TM CARBENICILLIN (K853685) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT METHICILLIN (K853772) | Austin Biological Laboratories | 1985-09-16 |
| PRECEPT TM MOXALACTAM (K853689) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT TM AMIKACIN (K853686) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT KANAMYCIN (K853684) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT NETILMICIN 32-13 (K853687) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT TM TOBRAMYCIN (K853688) | Austin Biological Laboratories | 1985-09-13 |
| PRECEPT ERYTHROMYCIN (K853053) | Austin Biological Laboratories | 1985-08-29 |
| PRECEPT AVGMENTIN (K853263) | Austin Biological Laboratories | 1985-08-29 |
| API UNISCEPT KB (K850347) | Analytical Products, Inc. | 1985-03-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MIC TEST PANELS (N50487/S015) | Microtech Medical Systems, Inc. | 1984-03-01 |
| MIC TEST PANELS (N50487/S011) | Microtech Medical Systems, Inc. | 1982-11-16 |
| MIC TEST PANELS (N50487/S012) | Microtech Medical Systems, Inc. | 1982-11-16 |
| MIC TEST PANELS (N50487/S013) | Microtech Medical Systems, Inc. | 1982-10-08 |
| MIC TEST PANELS (N50487/S010) | Microtech Medical Systems, Inc. | 1981-09-22 |
| MIC TEST PANELS (N50487/S006) | Microtech Medical Systems, Inc. | 1981-05-06 |
| MIC TEST PANELS (N50487/S008) | Microtech Medical Systems, Inc. | 1981-05-06 |
| UTI MIC TEST PANEL (N50487/S007) | Microtech Medical Systems, Inc. | 1981-05-06 |