FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BERICHROM HEPARIN
K Number: K925200
·
Decision Jun 28, 1993
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
45
Applicant Total
145
Review Days
255
Basic Information
- Device Name
- BERICHROM HEPARIN
- K Number
- K925200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7525
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BEHRING DIAGNOSTICS, INC.
- Date Received
- October 16, 1992
- Decision Date
- June 28, 1993
- Product Code
- KFF
- 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 |
|---|---|---|---|
| KFF | Assay, Heparin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFF), ordered by most recent decision date.
HemosIL Liquid Anti-Xa
FDA 510(k)
FDA Class 2
·Hematology
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
FDA 510(k)
FDA Class 2
·Hematology
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
FDA 510(k)
FDA Class 2
·Hematology
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
FDA 510(k)
FDA Class 2
·Hematology
ENOXAPARIN TEST CARD
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by BEHRING DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K973832 | OPUS HLH CONTROLS | Oct 27, 1997 | Substantially Equivalent |
| K972929 | N ANTISERUM TO HUMAN ALBUMIN | Oct 20, 1997 | Substantially Equivalent |
| K972840 | N ANTISERUM TO HUMAN TRANSFERRIN | Oct 17, 1997 | Substantially Equivalent |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | Sep 12, 1997 | Substantially Equivalent |
| K972316 | OPUS D-DIMER | Sep 9, 1997 | Substantially Equivalent |
| K972116 | VON WILLEBRAND REAGENT | Jul 25, 1997 | Substantially Equivalent |
| K972011 | OPUS ETHANOL | Jul 22, 1997 | Substantially Equivalent |
| K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) | Jun 25, 1997 | Substantially Equivalent |
| K971596 | EMIT II OPIATES 300/2000 ASSAY | Jun 25, 1997 | Substantially Equivalent |
| K964595 | OPUS PSA TEST SYSTEM | Jun 24, 1997 | Substantially Equivalent |