FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOCLOT PROTEIN S
K Number: K955738
·
Decision Feb 29, 1996
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
57
Review Days
76
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Basic Information
- Device Name
- BIOCLOT PROTEIN S
- K Number
- K955738
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Diagnostic Technologies, Inc.
- Date Received
- December 15, 1995
- Decision Date
- February 29, 1996
- Product Code
- GGP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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Other Clearances by Medical Diagnostic Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062229 | CTC WORKSTATION, MODEL 2200 | Sep 11, 2006 | Substantially Equivalent |
| K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) | Aug 12, 1997 | Substantially Equivalent |
| K963106 | CHROMOLIZE PAI-1 KIT | Nov 18, 1996 | Substantially Equivalent |
| K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | Aug 14, 1996 | Substantially Equivalent |
| K962489 | CHROMOLIZE TPA ASSAY KIT | Jul 31, 1996 | Substantially Equivalent |
| K960438 | TINTELIZE PAI-1 KIT | Jun 5, 1996 | Substantially Equivalent |
| K961724 | U-DOA CONTROLS | Jun 3, 1996 | Substantially Equivalent |
| K961370 | LA POSITIVE CONTROL PLASMA | May 24, 1996 | Substantially Equivalent |
| K955115 | VENOM TIEM REAGENT | Apr 3, 1996 | Substantially Equivalent |
| K952746 | ALKALINE PHOSPHATASE REAGENT SYSTEM | Nov 27, 1995 | Substantially Equivalent |