BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
FDA 510(k) clearance K043007 · decided 2005-11-07
Clearance details
- K-number
- K043007
- Device name
- BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
- Applicant
- Hyphen Biomed
- Decision
- Substantially Equivalent
- Date received
- 2004-11-01
- Decision date
- 2005-11-07
- Days to decision
- 371 days
- Clearance type
- Traditional
- Product code
- JBQ
- Device class
- 2
- Regulation number
- 864.7060
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mason, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INNOVANCE Antithrombin (K242952) | Siemens Healthcare Diagnostic Products GmbH | 2025-03-28 |
| INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (K081769) | Siemens Healthcare Diagnostics | 2009-05-28 |
| HEMOSIL ANTITHROMBIN (K070301) | Instrumentation Laboratory CO | 2007-02-23 |
| HEMOSIL LIQUID ANTITHROMBIN (K062431) | Instrumentation Laboratory CO | 2006-09-01 |
| HEMOSIL LIQUID ANTITHROMBIN XL (K033775) | Instrumentation Laboratory CO | 2004-01-02 |
| CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (K023991) | Precision Biologic | 2003-04-28 |
| COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550) | Instrumentation Laboratory CO | 2002-08-27 |
| COAMATIC AT-400 (K022195) | Instrumentation Laboratory CO | 2002-08-07 |
| IL TEST LIQUID ANTITHROMBIN (K994238) | Instrumentation Laboratory CO | 2000-06-23 |
| K-ASSAY AT-III (K000361) | Kamiya Biomedical Co. | 2000-04-26 |
| IL TEST ANTITHROMBIN (K980499) | Instrumentation Laboratory CO | 1998-04-02 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (K974110) | Beckman Instruments, Inc. | 1997-12-24 |
Recalls involving this device
No recalls on record reference this clearance.