SERIM RESIDUAL CHLORINE TEST KIT
FDA 510(k) clearance K901734 · decided 1990-09-13
Clearance details
- K-number
- K901734
- Device name
- SERIM RESIDUAL CHLORINE TEST KIT
- Applicant
- Serim Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-17
- Decision date
- 1990-09-13
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- FKJ
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Elkhart, IN, 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 |
|---|---|---|
| GUARDIAN™ Quick Dip Residual Chlorine (5212) (K253863) | Serim Research | 2026-03-17 |
| BBL GASPAK POUCH (K841307) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-05-14 |
| J.E.T. DIALYSIS SYSTEM (K820575) | Computer Dialysis Systems, Inc. | 1982-05-20 |
| TRANSDUCER PROTECTOR (K772040) | Terumo America, Inc. | 1977-11-28 |
Recalls involving this device
No recalls on record reference this clearance.