TECHNICON CHEM I SYSTEM MAGNESIUM METHOD
FDA 510(k) clearance K903306 · decided 1990-08-29
Clearance details
- K-number
- K903306
- Device name
- TECHNICON CHEM I SYSTEM MAGNESIUM METHOD
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-24
- Decision date
- 1990-08-29
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- JGJ
- Device class
- 1
- Regulation number
- 862.1495
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.