FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPUS T3
K Number: K953160
·
Decision Aug 24, 1995
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
145
Review Days
48
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Basic Information
- Device Name
- OPUS T3
- K Number
- K953160
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Behring Diagnostics, Inc.
- Date Received
- July 7, 1995
- Decision Date
- August 24, 1995
- Product Code
- CDP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDP), ordered by most recent decision date.
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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 |