OXALATE REAGENT
FDA 510(k) clearance K883525 · decided 1988-10-25
Clearance details
- K-number
- K883525
- Device name
- OXALATE REAGENT
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-17
- Decision date
- 1988-10-25
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- LPW
- Device class
- 1
- Regulation number
- 862.1542
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.