I-STAT COAGULATION CONTROL SET— 510(k) K981752
Substantially EquivalentBiopool Intl., Inc.
FDA 510(k) clearance K981752 for I-STAT COAGULATION CONTROL SET, Substantially Equivalent on 1998-06-15. Applicant: Biopool Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Biopool Intl., Inc.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
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More clearances from Biopool Intl., Inc.
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