ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
FDA 510(k) clearance K955356 · decided 1996-05-15
Clearance details
- K-number
- K955356
- Device name
- ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-21
- Decision date
- 1996-05-15
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- CGI
- Device class
- 1
- Regulation number
- 862.1265
- 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.