GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
FDA 510(k) clearance K961282 · decided 1996-06-21
Clearance details
- K-number
- K961282
- Device name
- GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
- Applicant
- Diagnostic Chemicals , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-03
- Decision date
- 1996-06-21
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- CFR
- Device class
- 2
- Regulation number
- 862.1345
- 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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Recalls involving this device
No recalls on record reference this clearance.