510(k) K010158
- Device
- THROMBOMAX-HS WITH CALCIUM, MODEL T6540
- Applicant
- SIGMA DIAGNOSTICS, INC.
- 510(k) number
- K010158
- Product code
- GGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-03-22
- Date received
- 2001-01-17
- Regulation
- 864.7925
- Classification name
- Reagent, Thromboplastin And Control
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM R GILBERT II
- Address
- 545 S. Ewing Ave. St. Louis MO US 63103 63103
Source Documents#
Legacy Summary#
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FDA Review#
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