DSL 17A-OH PROGERSTERONE (DSL #6800)
FDA 510(k) clearance K894265 · decided 1989-09-07
Clearance details
- K-number
- K894265
- Device name
- DSL 17A-OH PROGERSTERONE (DSL #6800)
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-22
- Decision date
- 1989-09-07
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- JLX
- Device class
- 1
- Regulation number
- 862.1395
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Webster, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.