(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
FDA 510(k) clearance K963627 · decided 1996-10-24
Clearance details
- K-number
- K963627
- Device name
- (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-11
- Decision date
- 1996-10-24
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.