FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
K Number: K924401
·
Decision Feb 22, 1994
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
39
Applicant Total
145
Review Days
540
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Basic Information
- Device Name
- PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
- K Number
- K924401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Behring Diagnostics, Inc.
- Date Received
- August 31, 1992
- Decision Date
- February 22, 1994
- Product Code
- GGC
- 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 |
|---|---|---|---|
| GGC | Control, Plasma, Abnormal | FDA class 2 | Hematology |
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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 |