CHLORIDE REAGENT
FDA 510(k) clearance K911297 · decided 1991-04-16
Clearance details
- K-number
- K911297
- Device name
- CHLORIDE REAGENT
- Applicant
- Intersect Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-25
- Decision date
- 1991-04-16
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- CHJ
- Device class
- 2
- Regulation number
- 862.1170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Longview, WA, 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 |
|---|---|---|
| PICCOLO CHLORIDE TEST SYSTEM (K010670) | Abaxis, Inc. | 2001-04-26 |
| 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (K945408) | Catachem, Inc. | 1995-02-22 |
| CHLORIDE QVET (K943006) | Prisma Systems | 1994-12-07 |
| OLYMPUS CHLORIDE REAGENT, MODIFICATION (K934136) | Olympus Corp. | 1993-11-05 |
| OLYMPUS CHLORID REAGENT, MODIFIED (K932528) | Olympus Corp. | 1993-09-17 |
| OLYMPUS CHLORIDE REAGENT (K925338) | Olympus Corp. | 1992-12-11 |
| KING DIAGNOSTICS CHLORIDE REAGENT (K922921) | King Diagnostics, Inc. | 1992-10-05 |
| OLYMPUS CHLORIDE REAGENT (K923610) | Olympus Corp. | 1992-10-02 |
| URINE CHLORIDE (K923036) | Heraeus Kulzer, Inc. | 1992-09-09 |
| CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED (K910133) | Olympus Corp. | 1991-02-27 |
| CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA. (K901500) | Olympus Corp. | 1990-07-10 |
| TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES (K892929) | Technicon Instruments Corp. | 1989-07-20 |
Recalls involving this device
No recalls on record reference this clearance.