SYNTHAFAX APTT REAGENT— 510(k) K955638
Substantially EquivalentOrtho Diagnostic Systems, Inc.
FDA 510(k) clearance K955638 for SYNTHAFAX APTT REAGENT, Substantially Equivalent on 1996-04-23. Applicant: Ortho Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho Diagnostic Systems, Inc.
- Product code
- Code GFO
- Device class
- Class 2
- Regulation
- 21 CFR 864.7925
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
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Recalls naming K955638
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955638.
Data sourced from openFDA. This site is unofficial and independent of the FDA.