SERACON(TM) CAL (PRODUCT NO. DO35)— 510(k) K862594
Substantially EquivalentBhp Diagnostix, Inc.
FDA 510(k) clearance K862594 for SERACON(TM) CAL (PRODUCT NO. DO35), Substantially Equivalent on 1986-08-19. Applicant: Bhp Diagnostix, Inc.. Device class: 2.
Clearance details
- Applicant
- Bhp Diagnostix, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
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