AMYLASE SR LIQUID STABLE REAGENT SET
FDA 510(k) clearance K885176 · decided 1989-02-17
Clearance details
- K-number
- K885176
- Device name
- AMYLASE SR LIQUID STABLE REAGENT SET
- Applicant
- Medical Analysis Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-14
- Decision date
- 1989-02-17
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- JFJ
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Camarillo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.