HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY— 510(k) K853239
Substantially EquivalentHaemachem, Inc.
FDA 510(k) clearance K853239 for HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY, Substantially Equivalent on 1985-11-05. Applicant: Haemachem, Inc.. Device class: 2.
Clearance details
- Applicant
- Haemachem, Inc.
- Product code
- Code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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