MICROSTAT 2
FDA 510(k) clearance K984485 · decided 1999-01-13
Clearance details
- K-number
- K984485
- Device name
- MICROSTAT 2
- Applicant
- Chemlink Laboratories, LLC
- Decision
- Substantially Equivalent
- Date received
- 1998-12-17
- Decision date
- 1999-01-13
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- LRJ
- Device class
- 1
- Regulation number
- 880.6890
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, 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 |
|---|---|---|
| CONTROL III ELITE (K992661) | Maril Products, Inc. | 1999-09-14 |
| PRO-PORTION CLEANER/DISINFECTANT (K991509) | Sultan Chemists, Inc. | 1999-07-14 |
| AMERSE 2 (K983947) | STERIS Corporation | 1998-12-04 |
| DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH (K983869) | Caltech Industries, Inc. | 1998-11-30 |
| LOW PH PHENOLIC 256 (K983585) | Central Solutions, Inc. | 1998-11-06 |
| CITREX HOSPITAL SPRAY DISINFECTANT (K982985) | Caltech Industries, Inc. | 1998-11-02 |
| KLEENASEPTIC (K981023) | Metrex Research Corp. | 1998-04-30 |
| T.B.Q. RTU (K980369) | STERIS Corporation | 1998-02-17 |
| GERMICIDAL CLOTH (K974304) | Convatec, A Division of E.R. Squibb & Sons | 1998-01-13 |
| NOVIGUARD QUICK DRY (K961044) | Dr. Novis Smith & Co., Inc. | 1997-07-03 |
| BLUE CHIP GERMICIDAL CLEANER & DEODORANT (K970825) | S.C. Johnson Professional | 1997-03-14 |
| CIDE-SWIPES P-100B & CIDE-SWIPES C-100A (K964376) | Mp Scientific, Inc. | 1996-12-23 |
Recalls involving this device
No recalls on record reference this clearance.