CHLORIDE (MF) ASSAY
FDA 510(k) clearance K934588 · decided 1994-02-18
Clearance details
- K-number
- K934588
- Device name
- CHLORIDE (MF) ASSAY
- Applicant
- Diagnostic Chemicals , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-23
- Decision date
- 1994-02-18
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- CHG
- Device class
- 2
- Regulation number
- 862.1170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Charlottetown, P.E.I., CA
- 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 |
|---|---|---|
| INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT (K941807) | Intersect Systems, Inc. | 1994-09-14 |
| SYNERMED CHLORIDE REAGENT KIT (K903103) | Synermed, Inc. | 1990-08-09 |
Recalls involving this device
No recalls on record reference this clearance.