AMMONIA ASSAY CAT. NO. 200-02
FDA 510(k) clearance K932556 · decided 1994-08-02
Clearance details
- K-number
- K932556
- Device name
- AMMONIA ASSAY CAT. NO. 200-02
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1993-05-26
- Decision date
- 1994-08-02
- Days to decision
- 433 days
- Clearance type
- Traditional
- Product code
- JIF
- Device class
- 1
- Regulation number
- 862.1065
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Charlottestown,Pei,Canada, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.