FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAG-A-MATE MTX III
K Number: K051030
·
Decision Dec 23, 2005
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
251
Review Days
245
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COAG-A-MATE MTX III
- K Number
- K051030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- bioMerieux, Inc.
- Date Received
- April 22, 2005
- Decision Date
- December 23, 2005
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPA), ordered by most recent decision date.
STA Satellite Max®
FDA 510(k)
FDA Class 2
·Hematology
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
FDA 510(k)
FDA Class 2
·Hematology
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
FDA 510(k)
FDA Class 2
·Hematology
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
FDA 510(k)
FDA Class 2
·Hematology
Citrated: K, KH, RTH, FFH
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP 970 CL
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by bioMerieux, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | Apr 15, 2026 | Substantially Equivalent |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | Aug 21, 2025 | Substantially Equivalent |
| K234012 | VITEK COMPACT PRO | Mar 14, 2025 | Substantially Equivalent |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | Jun 12, 2024 | Substantially Equivalent |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | Jun 7, 2024 | Substantially Equivalent |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | May 1, 2024 | Substantially Equivalent |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | Mar 11, 2024 | Substantially Equivalent |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | Oct 23, 2023 | Substantially Equivalent |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | Jul 5, 2023 | Substantially Equivalent |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | Jun 26, 2023 | Substantially Equivalent |